Carisma Therapeutics Presents Preclinical Proof of Concept Data Demonstrating the Anti-Fibrotic Potential of Engineered Macrophages at ASGCT 2024

Carisma Therapeutics Presents Preclinical Proof of Concept Data Demonstrating the Anti-Fibrotic Potential of Engineered Macrophages at ASGCT 2024

Novel anti-fibrotic engineered macrophage therapy reduced liver fibrosis in preclinical models

Development candidate nomination expected in the first quarter of 2025

PHILADELPHIA, May 8, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced new data demonstrating preclinical proof of concept using engineered anti-fibrotic macrophages for the treatment of liver fibrosis. The data was presented in a poster session at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting on May 8, 2024, in Baltimore, MD.

“We are pleased to unveil preclinical proof of concept data for our liver fibrosis program, which highlight the potential of engineered macrophages to combat a prevalent disease that is associated with late-stage metabolic dysfunction-associated steatohepatitis (MASH) and represents a significant unmet need,” said Michael Klichinsky, PharmD, PhD, Co-founder and Chief Scientific Officer of Carisma. “The data, from two independent models, demonstrate that engineered macrophages trafficked to fibrotic tissues, expressed genetically encoded disease-modifying payloads, and significantly reduced fibrosis in the liver. Given these encouraging data, we look forward to further progressing the liver fibrosis program, which is our first expansion outside of oncology.”

In the presentation titled “Genetically Engineered Macrophage Cell Therapy Reverses Liver and Lung Fibrosis in Preclinical Models,” Carisma presented preclinical proof-of-concept data for engineered macrophage cell therapy in liver fibrosis. In liver models, the data showed that a single dose of macrophages co-expressing the anti-fibrotic factor relaxin and the anti-inflammatory cytokine IL10 significantly improved established fibrosis in a CCl4-induced liver fibrosis model, with a 116% reduction in fibrosis relative to untreated control. Also, systemic administration of engineered macrophages co-expressing relaxin and IL10 significantly reduced liver fibrosis in a high fat diet MASH model, with a 45% reduction in fibrosis relative to untreated control. In both models, the relaxin-IL10 macrophage treatment also resulted in a greater reduction in liver fibrosis compared to non-engineered macrophages.

The presentation also included initial data for the use of engineered macrophages in pulmonary fibrosis. The data showed that a single dose of macrophages expressing a dominant negative TGFβ receptor, which nullified pro-fibrotic TGFβ signaling in the lung, prevented fibrosis in a bleomycin mouse model of pulmonary fibrosis, with a 90% reduction in fibrosis relative to untreated control.

Carisma expects to nominate a development candidate for its liver fibrosis program in the first quarter of 2025.

The poster presented at ASGCT 2024 is now available online in the “Publications” section of Carisma’s website at https://carismatx.com/technology/publications/

About Carisma 

Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.

Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (ii) Carisma’s ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iii) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (iv) Carisma’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (v) regulatory requirements or developments and Carisma’s ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vi) changes to clinical trial designs and regulatory pathways; (vii) risks associated with Carisma’s ability to manage expenses; (viii) changes in capital resource requirements; (ix) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (x) legislative, regulatory, political and economic developments.

For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investors:
Shveta Dighe
Head of Investor Relations

Media Contact:
Julia Stern
(763) 350-5223


MMI Receives FDA Authorization to Commercialize Symani® Surgical System in the U.S.

MMI Receives FDA Authorization to Commercialize Symani® Surgical System in the U.S.

De Novo Classification builds on proven clinical success and expands global access to new category of treatments

JACKSONVILLE, Fla. – April 8, 2024 – MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that its Symani Surgical System is now commercially available in the United States. The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the robotic system for soft tissue manipulation to perform microsurgery, a highly specialized technique that involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair.

The FDA authorization makes the Symani Surgical System the only commercially available platform in the U.S. for reconstructive microsurgery. The technology is positioned to open the field of microsurgery to new surgeons by quickly developing their skills, as well as to empower skilled microsurgeons to confidently expand into supermicrosurgery, creating a novel category of treatments that the human hand cannot perform without robotic assistance.

“The U.S. is facing a potentially dire shortage of physicians, and that shortage acutely impacts specialized fields of medicine, such as microsurgery,” said Mark Toland, CEO of MMI. “With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema. Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat.”

Specific techniques used in microsurgery include reconnecting small anatomical structures, such as blood and lymphatic vessels, during open surgical procedures. Supermicrosurgery involves reconstruction or repair of even smaller vessels, typically less than 1mm in diameter, and fewer than 600 surgeons worldwide perform supermicrosurgery today.

The Symani Surgical System provides advanced solutions for a range of open surgeries, including post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair.

“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” said Dr. L. Scott Levin, co-CMO of MMI. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance. The authorization from the FDA helps to solve a critical unmet need and will help surgeons perform a new category of complex open surgeries enabled by transformative technology.”

The Symani Surgical System offers surgeons entirely new capabilities because it features the world’s smallest surgical robotic wrist, called NanoWrist®. The unique design enables surgeons to replicate the natural movements of the human hand at the micro scale, which encourages a flatter learning curve in the training process. The articulated wrist features seven degrees of freedom that match the human wrist, tremor filtration and motion scaling, ultimately increasing precision and control.

Surgeons have leveraged the Symani Surgical System in nearly 1,000 clinical cases in the European Union and in thousands of preclinical cases around the world. The Symani Surgical System is available for commercial use in Europe and parts of Asia Pacific. MMI plans to immediately launch the technology in the U.S.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.


ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

FDA clearance would allow the Company to market its breakthrough therapy to improve or restore hand and arm function after spinal cord injury in the US

EINDHOVEN, the Netherlands — April 2, 2024 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI. Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical. ONWARD prioritized upper limb function as its first indication for the ARC-EX System given feedback from the SCI Community of the importance of arm, hand, and finger function in empowering independence after SCI.

“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”

The De Novo application follows the Company’s global pivotal study – called Up-LIFT – the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated the safety and effectiveness of ARC-EX Therapy in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the United States, Canada, the United Kingdom, and the Netherlands. The study met all primary safety and effectiveness endpoints and demonstrated that 72% of participants responded to ARC-EX Therapy1, showing improvement both in strength and function.

“The SCI Community is eager to have access to this innovative technology,” said Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation, Craig Hospital in Lakewood, Colorado. “Even a small difference in hand and arm function can have a profound impact on independence and quality of life. The results of the Up-LIFT trial that led to this submission represent a significant advancement in the use of neuromodulation for individuals with spinal cord injury.”

The ONWARD ARC-EX System delivers ARC-EX Therapy™ – targeted, programmed electrical stimulation – transcutaneously to the spinal cord to increase strength, movement, and function of the upper limbs after SCI. The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Nearly 200,000 people in the US and Europe have incomplete impaired upper extremity function after spinal cord injury.2,3 The Company is preparing for regulatory submission in Europe next.

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARCBCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

About ONWARD Medical
ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the Company has received ten Breakthrough Device Designations from the US Food and Drug Administration for its ARC Therapy™ platform.

ONWARD® ARC Therapy, which can be delivered by external ARC-EX® or implantable ARC-IM® systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company has submitted its De Novo regulatory clearance submission for ARC-EX for the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which
demonstrated positive interim clinical outcomes for improved blood pressure regulation, a component of hemodynamic instability, following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI) to address multiple symptoms of SCI.

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company also has an academic partnership with .NeuroRestore, a collaboration between the Swiss Federal Institute of Technology
(EPFL), and Lausanne University Hospital (CHUV).

ONWARD Medical is listed on Euronext Brussels and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Enquiries:
Aditi Roy, VP Communications

For Investor Enquiries:
Khaled Bahi, Interim CFO

Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions
that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. All ONWARD Medical devices and therapies referenced here, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™ and ARC Therapy™, are investigational and not available for commercial use.


Carisma Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Carisma Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Company to prioritize CT-0525 as its anti-HER2 CAR-M product candidate and will cease further development of CT-0508

Other prioritized pipeline programs include the Company's in vivo CAR-M collaboration with Moderna, and research programs including fibrosis

Cash and cash equivalents of $77.6 million as of December 31, 2023, combined with a restructuring of operations, including pausing development of CT-1119, expected to fund the Company into the third quarter of 2025

PHILADELPHIAApril 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (NASDAQ: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the fourth quarter, and full year ended December 31, 2023, and provided a business update.

“Clinical data generated with CT-0508 in Study 101 has shown that CAR-M is well-tolerated, feasible to manufacture and biologically active in HER2 positive solid tumors. Combining this data set with the multiple potential advantages we’ve seen preclinically around a monocyte-based approach gives us confidence that CT-0525 may be a significant advancement in CAR-M treatment,” said Steven Kelly, President and Chief Executive Officer of Carisma. “We have therefore made the decision to focus our resources on the clinical development of the product we believe is best suited to deliver benefit to patients with significant unmet need.”

Mr. Kelly continued, “We have also undertaken a careful review of our business and prioritized our other pipeline programs on those with the greatest overall potential and near-term milestones. This prioritization enables us to reduce expenses and streamline operations, including a restructuring of our workforce. I want to express my sincere gratitude to those impacted by the workforce reduction for their invaluable contributions to our mission and their dedication to helping patients.”

Reprioritization Plan, Pipeline Updates, and Upcoming Milestones:

Ex Vivo Oncology

  • Anti-human epidermal growth factor receptor 2 (Anti-HER2) Program
    • The Company’s goal to identify a registrational profile for the product candidate in its anti-HER2 program in 2025 remains unchanged.
    • In Study 101, CT-0508, a chimeric antigen receptor macrophage (CAR-Macrophage), was well-tolerated, remodeled the tumor microenvironment (TME), and induced anti-tumor T cell immunity in patients with HER2 3+ tumors that achieved stable disease, despite suboptimal dose and a patient population with exhausted T cells.
    • In late March 2024, Carisma made the decision to prioritize CT-0525, a chimeric antigen receptor monocyte (CAR-Monocyte), as the development candidate in its anti-HER2 program due to the potential for a CAR-Monocyte to have an approximately 2,000-fold increase in total exposure compared to a CAR-Macrophage. As a result, the Company believes that CT-0525 will be able to build on CT-0508’s observed clinical anti-tumor activity.

  • CT-0525 (Anti-HER2 CAR-Monocyte)
    • In November 2023, Carisma announced the clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for CT-0525.
    • The Company expects to treat the first patient in the CT-0525 Phase 1 clinical study in the second quarter of 2024 and to report initial data from the study by year-end 2024.
  • CT-0508 (Anti-HER2 CAR-Macrophage)
    • In September 2023, the Company reported preliminary data from 14 patients in the open label Phase 1 clinical study of CT-0508 (Study 101) designed to evaluate the safety, tolerability and manufacturing feasibility of CT-0508 along with several customary secondary endpoints.
    • The Company has also enrolled six patients in a Study 101 substudy evaluating the co-administration of CT-0508 and pembrolizumab, a programmed cell death protein 1 (PD-1) checkpoint inhibitor, evaluating the safety and tolerability of the co-administration, along with several customary secondary endpoints.
    • While the Company will continue all study operations for subjects enrolled in Study 101, it plans to stop recruitment of new patients into the study and its substudies, and expects to report data from the substudy evaluating the co-administration of CT-0508 and pembrolizumab in the second quarter of 2024.

  • CT-1119 (Anti-Mesothelin CAR-Monocyte)
    • The Company has elected to pause further development of CT-1119 as part of its reprioritization plan, pending additional financing.

In Vivo Oncology

  • Oncology (CAR-M + mRNA/LNP; Moderna Collaboration)
    • In November 2023, Carisma presented pre-clinical data from its in vivo program demonstrating that chimeric antigen receptor macrophages and monocytes (CAR-M) can be directly produced in vivo, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. The data demonstrated feasibility, tolerability, and efficacy of in vivo CAR-M against metastatic solid tumors.
    • In December 2023, the Company announced the nomination of the first lead candidate in its collaboration with Moderna Tx, Inc., which will target an antigen present on a solid tumor with significant unmet medical need.

Fibrosis and Immunology

  • Liver Fibrosis
    • Pre-clinical proof of concept data from the fibrosis program is targeted for the second quarter of 2024.

Corporate Updates

  • As a result of the pipeline reprioritization and corporate restructuring, Carisma plans to reduce its workforce by approximately 37% in the second quarter of 2024.

  • On April 1, 2024, Carisma announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Dr. Hohneker brings over 30 years of extensive experience in drug development and leadership across the biotech and pharmaceutical sectors. The Company concurrently announced the resignation of Chidozie Ugwumba from Carisma’s Board of Directors, also effective April 1, 2024.

Fourth Quarter and Full Year 2023 Financial Results

  • Cash and Cash Equivalents: As of December 31, 2023, Carisma had cash and cash equivalents of $77.6 million.

  • R&D Expenses: Research and development (R&D) expenses were $19.4 million and $74.1 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $18.1 million and $56.6 million for the fourth quarter and full year ended December 31, 2022, respectively. The increase of $17.5 million year-over-year was primarily due to a $8.4 million increase in direct costs associated with pre-clinical development of CT-0525, a $4.4 million increase in personnel costs due to growth in research and development employee headcount, a $2.7 million increase in the Company’s facilities and other expenses resulting from increased laboratory space and laboratory supplies from expanded clinical and pre-clinical work, a $1.3 million increase due to costs associated with growth and expansion of pre-clinical activities towards submission of an IND for CT-0525, and a $0.9 million increase in direct costs associated with the pre-clinical development related to CT-1119, partially offset by a $0.2 million decrease in direct costs associated with CT-0508. The Company expects its research and development expenses to decrease in 2024 as it implements the revised operating plan, including a reduction in workforce, prioritization of CT-0525 and a pause in development of CT-1119. The Company expects that its expenses will increase again in future years as it continues to advance its clinical trials and potentially progress additional product candidates.

  • G&A Expenses: General and administrative (G&A) expenses were $7.3 million and $29.5 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $1.0 million and $9.4 million for the fourth quarter and full year ended December 31, 2022, respectively. The increase of $20.1 million year-over-year was primarily attributable to a $9.2 million increase in personnel costs and a $7.5 million increase in professional fees. The increase in personnel costs was primarily due to non-recurring severance and other costs associated with the merger with Sesen Bio, Inc. on March 7, 2023 (“Merger”) of $4.6 million, and higher personnel costs as a result of an increase in headcount to support operating as a public company of $4.6 million. The increase in professional fees primarily consisted of $5.3 million in costs associated with activities to support the transitioning to and operating as a public company and protecting the Company’s IP portfolio, along with $2.2 million in legal fees and communication fees associated with the Merger. Insurance and taxes increased $2.1 million as a result of costs associated with operating as a public company, such as director and officer insurance. Facilities and supplies increased $0.8 million due to office expenditures resulting from an increased footprint, and other expenses increased $0.5 million. The Company expects that its general and administrative expenses will decrease in 2024 as its 2023 expenses included a significant amount of non-recurring costs related to the Merger and as it implements its revised operating plan, including reducing its workforce and decreasing expenses related to non-essential activities.

  • Net Loss: Net loss was $86.9 million and $61.2 million for the years ended December 31, 2023, and 2022, respectively.

Outlook

Carisma anticipates that its cash and cash equivalents of $77.6 million as of December 31, 2023, combined with the expected cost savings from implementing the revised operating plan, are sufficient to sustain its planned operations into the third quarter of 2025.

About CT-0525

CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to CT-0508.

About CT-0508

CT-0508 is an ex vivo gene-modified autologous chimeric antigen receptor-macrophage (CAR-Macrophage) cellular therapy intended to treat solid tumors that overexpress HER2. It is being evaluated in a Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans.

About Carisma

Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.

Cautionary Note on Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (ii) Carisma’s ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iii) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (iv) Carisma’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (v) regulatory requirements or developments and Carisma’s ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vi) changes to clinical trial designs and regulatory pathways; (vii) risks associated with Carisma’s ability to manage expenses; (viii) changes in capital resource requirements; (ix) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (x) legislative, regulatory, political and economic developments.

For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investors:
Shveta Dighe
Head of Investor Relations

Media:
Julia Stern
(763) 350-5223

CARISMA THERAPEUTICS INC.

Consolidated Balance Sheets

(in thousands, except share and per share data)

December 31,

Assets

2023

2022

Current assets:

Cash and cash equivalents

$

77,605

$

24,194

Marketable securities

27,802

Prepaid expenses and other assets

2,866

2,596

Total current assets

80,471

54,592

Property and equipment, net

6,764

8,628

Right of use assets – operating leases

2,173

4,822

Deferred financing costs

146

4,111

Total assets

$

89,554

$

72,153

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Current liabilities:

Accounts payable

$

3,933

$

1,728

Accrued expenses

7,662

10,361

Deferred revenue

1,413

2,459

Operating lease liabilities

1,391

3,437

Finance lease liabilities

544

1,162

Other current liabilities

965

523

Total current liabilities

15,908

19,670

Deferred revenue

45,000

45,000

Convertible promissory note

33,717

Derivative liability

5,739

Operating lease liabilities

860

976

Finance lease liabilities

328

872

Other long-term liabilities

926

1,041

Total liabilities

63,022

107,015

Convertible preferred stock

107,808

Stockholders’ equity (deficit):

Preferred stock $0.001 par value, 5,000,000 shares authorized, none
issued or outstanding

Common stock $0.001 par value, 350,000,000 shares authorized,
40,609,915 and 2,217,737 shares issued and outstanding at December 31,
2023 and 2022, respectively

40

2

Additional paid-in capital

271,594

1,197

Accumulated other comprehensive loss

(41)

Accumulated deficit

(245,102)

(158,223)

Total Carisma Therapeutics Inc. stockholders’ equity (deficit)

26,532

(157,065)

Noncontrolling interests

14,395

Total stockholders’ equity (deficit)

26,532

(142,670)

Total liabilities, convertible preferred stock and
stockholders’ equity (deficit)

$

89,554

$

72,153

CARISMA THERAPEUTICS INC.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Three Months Ended
December 31,

Year Ended
December 31,

2023

2022

2023

2022

Collaboration revenues

$

4,289

$

3,731

$

14,919

$

9,834

Operating expenses:

Research and development

19,415

18,082

74,125

56,618

General and administrative

7,324

971

29,525

9,378

Total operating expenses

26,739

19,053

103,650

65,996

Operating loss

(22,450)

(15,322)

(88,731)

(56,162)

Change in fair value of derivative liability

(550)

(84)

(1,919)

Interest income (expense), net

1,295

(867)

1,936

(3,145)

Pre-tax loss

(21,155)

(16,739)

(86,879)

(61,226)

Income tax provision

197

Net loss

$

(20,958)

$

(16,739)

$

(86,879)

$

(61,226)

Share information:

Net loss per share of common stock, basic and diluted

$

(0.52)

$

(7.61)

$

(2.59)

$

(28.77)

Weighted-average shares of common stock
outstanding, basic and diluted

40,391,608

2,198,748

33,524,197

2,128,069

Comprehensive loss

Net loss

$

(20,958)

$

(16,739)

$

(86,879)

$

(61,226)

Unrealized gain (loss) on marketable securities

26

119

440

(41)

Less: reclassification to net loss of previous
unrealized gain on marketable securities

(399)

(399)

Comprehensive loss

$

(21,331)

$

(16,620)

$

(86,838)

$

(61,267)

SOURCE Carisma Therapeutics Inc.


Carisma Therapeutics Announces Changes to its Board of Directors

Carisma Therapeutics Announces Changes to its Board of Directors

Appointment of John Hohneker, M.D.

Resignation of Chidozie Ugwumba

PHILADELPHIA, April 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Additionally, the Company announced that Chidozie Ugwumba, who has served on Carisma’s Board of Directors since December 2020, has advised the Board of his intent to step down from his role as a member of the Board and chair of the Audit Committee of the Board effective April 1, 2024, as a result of his other professional commitments.

“We are pleased to welcome John to the Carisma Board of Directors,” said Sanford Zweifach, Chair of the Carisma Board of Directors. “I believe John’s extensive track record of clinical development, strategic leadership, and public company Board membership in the biopharmaceutical space will enable him to immediately support the Company as it continues leading the field of engineered macrophage development. We would also like to thank Chidozie for his invaluable advice and guidance since he first joined the Board over three years ago.”

“I am excited to join Carisma’s Board as the Company continues to develop innovative immunotherapies,” said Dr. Hohneker. “I am looking forward to partnering with the Board and the management team as they work to potentially bring novel treatments to patients in need across multiple therapeutic areas.”

Dr. Hohneker brings over 30 years of extensive experience in drug development and leadership across the biotech and pharmaceutical sectors. He most recently served as President and Chief Executive Officer of Anokion SA. Prior to this, he held the role of President of Research and Development at FORMA Therapeutics Inc. Before joining FORMA Therapeutics, Dr. Hohneker held roles of increasing responsibility at Novartis AG, including most recently as Senior Vice President and Global Head of Development, Immunology, and Dermatology. Prior to his time at Novartis, Dr. Hohneker held positions of increasing responsibility at Glaxo Wellcome and its legacy company, Burroughs Wellcome.

Dr. Hohneker currently serves on the Board of Directors of Curis, Inc., Sonata Therapeutics, Inc., and Trishula Therapeutics, Inc. Previously, Dr. Hohneker has served as a member of the Board of Directors of Torque Therapeutics, Inc., Dimension Therapeutics, Inc., Cygnal Therapeutics, Inc., BioTheryX Inc., Evelo Biosciences, Inc., Humanigen, Inc. and Aravive, Inc. Dr. Hohneker received his bachelor’s degree in chemistry from Gettysburg College and his M.D. from the Rutgers School of Biomedical and Health Sciences (formerly the University of Medicine and Dentistry of New Jersey-Rutgers Medical School). He completed his internship and residency in internal medicine and his fellowship in medical oncology, all at the University of North Carolina at Chapel Hill.

About Carisma

Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.

Investors:
Shveta Dighe
Head of Investor Relations

Media Contact:
Julia Stern
(763) 350-5223


TRiCares Announces the Appointment of Ahmed Elmouelhi as President & Chief Executive Officer

Paris, France and Munich, Germany, March 25, 2024 – TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, today is pleased to announce the appointment of Ahmed Elmouelhi as President & Chief Executive Officer (CEO). In conjunction with this, and following eight years at the helm of the business, Helmut Straubinger is retiring as President & CEO.

Ahmed Elmouelhi is a seasoned professional with more than 20 years of medical device experience across strategy, sales and marketing, R&D, and clinical science. Before joining TRiCares, Ahmed served as the Senior Vice President of Product Marketing, Strategy, and Business Development at AtriCure. There, he was instrumental in the establishment of Left Atrial Appendage (LAA) therapies and the creation of two successful business franchises for the company.  Previously, Ahmed held roles of increasing responsibility at Medtronic, within its Structural Heart division, as well as AGA Medical (now part of Abbott Laboratories), where he led cross-functional teams to launch multiple generations of Transcatheter Aortic Valve Replacement (TAVR) therapies and accessories, Congenital Heart Defect therapies, and percutaneous LAA devices.

Ahmed studied at Massachusetts Institute of Technology where he obtained both his Masters and Bachelors in Mechanical Engineering with a minor in Economics. He currently serves as the Chairman of the American Heart Association in Minnesota.

Since joining the business in March 2016, Helmut has overseen the development of the first European minimally invasive implantable tricuspid valve, bringing it to first-in-man clinical use. Helmut will work with Ahmed to provide a seamless transition before his retirement at the end of March and will continue to support the team on a consultancy basis.

Eric Fain, MD, Chairman of TRiCares, commented: “I would like to extend my thanks to Helmut, on behalf of the board of directors, for his efforts over many years in leading TRiCares to successfully develop the leading transcatheter tricuspid replacement technology and demonstrate its initial strong clinical performance. After evaluating many candidates for the next CEO, I am confident that Ahmed is the right person to drive the company’s success as it enters its next phase.”

Ahmed Elmouelhi, newly appointed President & CEO of TRiCares, added: “This is an exciting time to be joining the business, and I am looking forward to leading the team over the coming months and years. The potential for Topaz is clear, and the need great, with 1.8 million patients suffering from Tricuspid heart valve regurgitation in the US alone. Helmut leaves a significant legacy after many years with the business, and I wish him the best for his retirement.”

Helmut Straubinger, former President & CEO of TRiCares, commented: “I would like to express my heartfelt gratitude to the entire TRiCares team for their unwavering commitment and hard work over the last eight years. As the company looks towards the US, this is the right moment for a change in leadership. I look forward to following TRiCares’ progress under Ahmed’s guidance, as it seeks to benefit Tricuspid regurgitation patients globally.”

 

Press inquiries:

 


Bayer and Aignostics to collaborate on next generation precision oncology

Bayer and Aignostics to collaborate on next generation precision oncology

  • Strategic multi-year research collaboration to identify novel targets with strong disease links and to accelerate clinical development, further strengthening Bayer’s precision oncology development portfolio
  • Co-development of a novel target identification platform leveraging multimodal patient data and industry-leading AI/ML algorithms
  • Development of computational pathology algorithms connecting baseline data such as molecular tumor profiles with patient outcome to enable better patient identification, stratification, and selection for clinical trials  

Berlin, Germany, March 14, 2024 – Bayer and Aignostics GmbH today announced a strategic collaboration on several artificial intelligence (AI)-powered approaches with applications in precision oncology drug research and development. Aignostics is a spin-off from one of the world’s leading hospitals, Charité-Universitätsmedizin Berlin, and a global leader in using computational pathology to transform complex biomedical data into biology insights.

The partners will co-create a novel target identification platform that leverages Aignostics’ technology and proprietary multimodal patient cohorts, and Bayer’s deep expertise in discovering and developing novel oncology therapies. In addition, the collaboration will include the development of computational pathology algorithms powered by AI and machine learning (ML) that connect baseline pathology data, such as molecular tumor profiles, with clinical data, such as patient outcomes, to enable better patient identification, stratification, and selection for clinical trials.

The goal of the multi-year research collaboration is to identify novel cancer targets with a strong disease link through AI models applied to multimodal patient data and to accelerate clinical development of oncology programs. This approach has the potential to address some of the challenges currently experienced in target discovery and disease heterogeneity.

“Gaining insights into human disease biology, discovering targets with a strong disease link by integrating artificial intelligence, machine learning and multimodal pathology into precision drug development has a huge potential for our R&D innovation strategy,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “Bringing Aignostics’ technical knowhow and their access to large patient datasets together with Bayer’s expertise in cancer research and development will enable discoveries and faster clinical development, helping to provide cancer patients with more impactful medicines.”

The collaboration will leverage Aignostics’ technology and access to longitudinal, multimodal clinical data sets in well characterized patient cohorts to discover new oncology targets for high unmet medical need indications. Under the terms of the agreement, the companies will collaborate on multiple discovery programs and initiate at least two target identification programs.

“Innovation at Aignostics has always been fueled by close collaboration with clinicians and biopharma. With this partnership, we’re thrilled to take that approach to the next level. Fusing our technology and multimodal data with Bayer’s extensive expertise in drug discovery and clinical development has the potential to generate better drugs for patients with high unmet need in less time. Together with Bayer, we’re excited to transform AI’s immense potential into a reality for healthcare,” said Viktor Matyas, CEO of Aignostics GmbH.

Aignostics will receive an upfront payment and is eligible to receive success-based milestone payments and royalties on any commercialized therapies that result from the collaboration.

About Aignostics
Aignostics combines proprietary access to multimodal clinical datasets, industry-leading AI technologies, and rigorous science to develop best-in-class insights for the next generation of precision medicine. Through collaborations with its biopharma partners, Aignostics supports drug discovery, translational research, clinical trials, and CDx development across multiple therapeutic areas. Established in 2018, Aignostics is a spin-off from Charité Berlin, one of the world’s largest and most esteemed university hospitals. Aignostics is funded by leading VC investors and has operations in Berlin and New York.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Bayer Media Contact:
Julia Schulze, phone +49 175 5866 432
Email:

Aignostics Media Contact:
MC Services AG, Kaja Skorka, Dr. Regina Lutz, phone: +49 89-210 2280
Email:

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

Find more information at https://aignostics.com/
Follow us on LinkedIn: https://www.linkedin.com/company/aignostics

jds (2024-0053E)

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


MMI Raises $110 Million in Series C Financing

MMI Raises $110 Million in Series C Financing

Largest ever investment in microsurgery will further MMI’s mission to transform open surgery with robotic technology

JACKSONVILLE, Fla.–(BUSINESS WIRE)–MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that it has raised $110 million in Series C financing. The round, led by Fidelity Management & Research Company, marks the largest ever investment in microsurgery innovation.

The funds will support commercialization of the Symani® Surgical System in high-growth markets and continued investment in studies that generate clinical evidence and enable indication expansion. Investments will also accelerate advanced technology capabilities and enable MMI to scale its operational capabilities globally.

MMI and its existing investors, all of whom contributed to the Series C financing, see considerable opportunity for rapid growth. The company projects the market for eligible robotic microsurgical procedures will grow from 3 million to 22 million annually by 2028, driven primarily by technological advancements and indication expansion.

“Against a backdrop of plateauing investments in medical robotics, this support builds on our confidence in a new, less invasive solution for open surgery, a significant market that can benefit from the smallest wristed microinstruments,” said Mark Toland, CEO of MMI. “Our Symani Surgical System is uniquely positioned to expand patient access to care by accelerating the number of surgeons able to perform complex, delicate procedures. With the support of our investors, we will continue to advance our technology through a growing body of clinical evidence and expanded hospital partnerships.”

The Symani Surgical System is a first-of-its-kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can expand treatment options for patients in need of soft tissue, open surgical procedures, such as free flap reconstructions, lymphatic surgery, and trauma replantations. It is designed to help restore quality of life for more patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

MMI has raised over $200 million in funding to date. In 2022, it closed a Series B financing round to propel growth. The funding was allocated to help expand indications and support ongoing commercialization efforts for the Symani Surgical System in Europe, where it received CE mark in 2019, accelerate plans to commercialize in the U.S. and Asia-Pacific, and advance clinical research.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair, lymphatic repair, and peripheral nerve repair. The Symani System is CE Marked for commercial use in Europe. In the United States, the system is not approved or cleared for commercial use. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.


UroMems Announces Results of First-Ever Smart Artificial Urinary Sphincter Implant in Female Patient to Treat Stress Urinary Incontinence

UroMems Announces Results of First-Ever Smart Artificial Urinary Sphincter Implant in Female Patient to Treat Stress Urinary Incontinence

Positive results demonstrate promising new option for women seeking better, personalized treatment

GRENOBLE, France and MINNEAPOLISFeb. 14, 2024 /PRNewswire/ — UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI. This milestone indicates a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the female patient was treated, but also across Europe and the U.S. It also follows closely on the heels of the successful results of the complete treatment cohort of the first-in-man clinical feasibility study. Results of this clinical study will contribute to the design and implementation of UroMems’ pivotal clinical trial in Europe and the U.S.

“On behalf of the medical team who implanted the UroActive System in the first female patient, Drs. Christophe Vaessen, Aurelien Beaugerie and I are over the moon to see our first patient has returned to living life fully after years of struggling with SUI,” said Professor Emmanuel Chartier-Kastler. “This promising therapy is a breakthrough technology in treating SUI in both women and men.”

The primary outcome measures include the successful device activation and the rate of explants and revisions at six months. The first female patient has not only met the study’s primary endpoints by remaining revision-free but is also experiencing restored social continence. Follow-up on secondary measures, including leak rate values, has been extremely positive.

“As the leading advocacy organization in the U.S. supporting patients and caregivers with urinary incontinence, we hear from patients weekly looking for information on the safety and efficacy of artificial sphincters. Unfortunately, we have little to report back and support their requests as no one in the U.S. actively promotes this option for women,” said Steven Gregg, Ph.D., executive director of the National Association for Continence. “These results of the first UroActive System implanted in a female represent a promising development to treat stress urinary incontinence in both women and men. We’re excited about this first-of-its-kind development and look forward to UroMems’ pivotal trial results.”

Pending those results, the potential for U.S. surgeons to offer this new option is now on the horizon; skilled surgeons performing robotic-assisted surgeries such as sacrocolpopexies and hysterectomies may soon be able to add implanting UroActive to their standard practices. UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethra in men and the bladder neck in women, controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

“We are elated to reach this critical achievement contributing to the demonstration of the feasibility of the UroActive System to successfully treat women suffering from debilitating SUI,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “The compelling results of this first-in-female implant show the high potential of our technology, bringing us one step closer to delivering on the massive unmet need for women and physicians desperately seeking a better SUI treatment option.”

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma.

UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from poorly treated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of embedded systems and micro-technologies for the development of its groundbreaking solutions.

About UroActive
UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 120 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience. STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

For more information, please visit www.uromems.com.

Media Contact:
Shelli Lissick

651-276-6922

 


eGenesis and OrganOx Announce Successful Use of a Genetically Engineered Porcine Liver with a Human Donor

eGenesis and OrganOx Announce Successful Use of a Genetically Engineered Porcine Liver with a Human Donor

72-hour proof-of-concept procedure at Penn Medicine marks longest perfusion using genetically
engineered porcine organ designed for liver support

Cambridge, Mass. (January 18, 2023) – eGenesis, a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, and OrganOx, a medical device company with a focus on the therapeutic applications of isolated organ perfusion, today announced the successful completion of an extracorporeal perfusion of a brain-dead research donor using a genetically engineered porcine liver. The donor was the first to be enrolled in the ongoing PERFUSE-2 study.

The study, made possible through the generosity of a donor family seeking to help other families through the advancement of clinical research, was carried out in collaboration with the University of Pennsylvania Transplant Institute and Gift of Life Donor Program. The perfusion was performed using the eGenesis liver, EGEN-5784, connected to the OrganOx extracorporeal liver cross-circulation (ELC) device to enable circulation of the donor’s blood through the porcine liver. Stable blood flow, pressure, and pH were achieved throughout the procedure in addition to robust bile production. No evidence of rejection was observed. The perfusion was electively stopped per-protocol at 72 hours with the liver appearing healthy.

The PERFUSE-2 study is being conducted to evaluate the feasibility of using this liver perfusion system to support patients suffering from liver failure. Annually in the US, over 300,000 patients are admitted with various forms of liver failure, requiring treatment in the acute setting. The efficacy of existing liver support options is limited, and patients in liver failure face a high risk of mortality. For some patients, utilizing a human-compatible, genetically engineered porcine whole liver to support the function of a patient’s decompensated liver may provide time for the recovery of the patient’s native liver or time to obtain a liver transplant. eGenesis and OrganOx are co-developing this technology and anticipate submitting an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) in 2024 to initiate a first-in-human clinical study.

The genetically engineered porcine liver used in this study carried the same genetics as the porcine kidneys used in the landmark preclinical study recently published in Nature. These edits include (1) knock out of three genes involved in the synthesis of glycan antigens implicated in hyperacute rejection, (2) insertion of seven human transgenes involved in the regulation of several pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome.

“We wish to extend our deepest gratitude to the donor and their family for enabling this important medical achievement and for paving the way for future work toward a potential solution for the many patients in need of life-saving liver support,” said Michael Curtis, Ph.D., President and Chief Executive Officer of eGenesis. “In addition to being a first in the field of xenotransplantation, this study provides important information to help advance our IND application.”

Abraham Shaked, M.D., Ph.D. of the University of Pennsylvania Transplant Institute said, “The success of this study provides support for further exploration of organ products developed using advanced genome engineering to provide novel, high-quality therapeutic options for individuals experiencing organ failure.”

“This marks a key milestone in our journey towards an effective treatment for acute liver decompensation. The OrganOx ELC system combined with a genetically engineered liver from eGenesis links modern organ perfusion technology with the functions of a whole liver, with the goal of providing a treatment that offers a lifeline to the critically ill patient – time for their own liver to recover or time to receive a transplant,” said Prof Peter Friend, Chief Medical Officer, OrganOx.

“Gift of Life Donor Program, one of the nation’s leading organ procurement organizations, is proud to have collaborated on this pioneering study that has the potential to bring new hope to waitlist patients by providing a bridge to transplant or time for healing,” said Richard D. Hasz, Jr., MFS, CPTC, President and CEO, Gift of Life Donor Program. “This unique study was only possible thanks to the generosity of a donor family willing to help alleviate the suffering of others despite their own personal loss. Every day, we are inspired by the kindness of families who choose donation. We look forward to partnering with Penn Medicine, eGenesis and OrganOx on future trials to advance this evolving field of medicine.”

“Our family is very proud to support this medical advancement and see our loved one’s legacy benefit countless others,” said a member of the donor family. “It is a testament to our loved one’s selflessness and compassion to know this donation offers such hope for people suffering serious disease in the future.”

About OrganOx
OrganOx is a commercial stage UK-based medical device company with a focus on the therapeutic applications of isolated organ perfusion. Its first product, the OrganOx metra normothermic liver machine perfusion system, has been used to support more than 3000 liver transplant operations globally, optimizing the use of donated organs by enabling assessment of the quality of livers as well as longer preservation durations. Other therapeutic applications, including in kidney transplantation, are in development. Learn more at www.organox.com

About eGenesis
eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs. The eGenesis Genome Engineering and Production (EGEN™) Platform is the only technology of its kind to comprehensively address cross-species molecular incompatibilities and viral risk via genetic engineering. eGenesis has demonstrated durable preclinical success to date and is advancing development programs for acute liver failure, kidney transplant, and pediatric as well as adult heart transplant. Learn more at www.egenesisbio.com.

Media Contact
eGenesis Kimberly Ha

OrganOx
Daniel Woodward