ONWARD® Medical Announces Third Implant of BrainComputer Interface (BCI) System to Restore Movement after Spinal Cord Injury
ONWARD® Medical Announces Third Implant of BrainComputer Interface (BCI) System to Restore Movement after Spinal Cord Injury
Company continues pioneering research on BCI-enabled system to restore mobility after spinal cord injury
EINDHOVEN, the Netherlands — September 19, 2024 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), announces another successful implant of its investigational ARC-BCI™ System to restore lower limb mobility after SCI.
The ARC-BCI System combines the investigational ONWARD ARC-IM® System (an implanted technology that delivers targeted stimulation to the spinal cord) with the investigational WIMAGINE® BCI from CEA-Clinatec to create a DigitalBridge™ across the injured spinal cord. The implant procedure was performed on September 12, 2024, by Jocelyne Bloch, MD, head of functional neurosurgery at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne,
Switzerland.
“The procedure went smoothly, and early signs are encouraging,” said neurosurgeon Dr. Jocelyne Bloch. “We look forward to sharing more information in the coming months as the participant progresses in their rehabilitation and we publish observations from the study.”
This implant is part of an ongoing clinical feasibility study supported by a grant from the European Innovation Council under the Reverse Paralysis project and coordinated by .NeuroRestore, a Swiss neuroscience research institute. The researchers are also exploring use of the ONWARD ARC-BCI System to address upper limb movement challenges after SCI in a separate early feasibility clinical study funded by the Christopher & Dana Reeve Foundation.
The WIMAGINE BCI from CEA-Clinatec is an epidurally-implanted device with 7 years of human safety data; ONWARD ARC-IM Therapy has now been applied in more than 30 study participants.
“While other companies race to develop BCIs to communicate with and control computers, ONWARD Medical stands alone in our commitment to exploring the potential for this promising technology to restore movement of the human body after paralysis,” said Dave Marver, CEO of ONWARD Medical. “We salute our brilliant partners at CEA-Clinatec and .NeuroRestore for their important contributions to this research.”
This latest news marks the third human implant of the WIMAGINE BCI paired with ARC-IM Therapy to restore thought-enabled movement after SCI and the second for lower limb mobility. The first human use of ARC-BCI Therapy for lower limb mobility occurred in 2021, with results describing the individual’s augmented control over when and how he moved his paralyzed legs published in Nature in May 2023. In the fall of 2023, an individual was implanted to explore the potential for ARC-BCI Therapy to restore upper extremity function after SCI.
Earlier this year, the Company announced that it has been accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP) for its ARC-BCI platform. Prior to the acceptance, the Company announced its ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration. This is the Company’s 10th such award.
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 scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).
ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX® or implantable ARC-IM® platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI™ platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.
Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for
regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease as well as using the ARC-BCI platform to restore thoughtdriven movement of both upper and lower limbs after 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 is listed on Euronext Brussels and Amsterdam (ticker: ONWD).
For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.
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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, delays in regulatory approvals, 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 forwardlooking 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 and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases
Carisma and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases
Building on successful pre-clinical in vivo CAR-M data in oncology, the companies will develop in vivo CAR-M for autoimmune diseases
Moderna nominated two autoimmune disease targets under the collaboration
Carisma is eligible to receive milestones and royalty payments
PHILADELPHIA, Sept. 10, 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 expansion of its in vivo chimeric antigen receptor macrophage and monocyte (together, “CAR-M”) collaboration with Moderna, Inc. (Nasdaq: MRNA) to include the nomination of two targets for the treatment of autoimmune diseases. Carisma retains all rights in autoimmune disease beyond the two nominated targets, which will be exclusively partnered with Moderna.
Under this expanded collaboration, Carisma and Moderna will leverage Carisma’s proprietary CAR-M technology and Moderna’s mRNA/LNP platform to develop novel in vivo macrophage engineering approaches in the nominated autoimmune disease targets. Carisma will receive research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized under the collaboration agreement. Carisma will be responsible for the discovery and optimization of development candidates, while Moderna will lead the clinical development and commercialization of therapeutics resulting from the agreement.
“We are excited to expand our collaboration with Moderna into the realm of autoimmune diseases,” said Steven Kelly, President and Chief Executive Officer of Carisma. “The nomination of the two autoimmune targets is a significant milestone in our mission to harness the power of macrophages to treat a broader range of diseases. Our innovative CAR-M technology has the potential to revolutionize the treatment landscape for patients suffering from these debilitating conditions.”
“We are excited to build on the progress of advancing in vivo CAR-M therapies with Carisma by expanding beyond oncology,” said Lin Guey, PhD, CSO of Therapeutic Research Ventures, Moderna. “We continue to believe that the combination of our platform and Carisma’s deep myeloid biology expertise could lead to innovative treatments for patients.”
The expanded collaboration between Carisma and Moderna underscores the potential of CAR-M technology to impact a diverse range of disease areas. The expansion will aim to bring transformative therapies to patients with cancer and autoimmune diseases, advancing the frontier of immunotherapy.
About Carisma Therapeutics
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 realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) 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; (iv) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) 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; (vi) 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; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma’s ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) 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, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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.
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SOURCE Carisma Therapeutics Inc.
CorFlow Therapeutics AG completes €44 million Series B financing to support the advancement of a novel diagnostic and drug delivery platform for microvascular obstruction (MVO) in heart attack patients
CorFlow Therapeutics AG completes €44 million Series B financing to support the advancement of a novel diagnostic and drug delivery platform for microvascular obstruction (MVO) in heart attack patients
The Series B funding enables both an International Pivotal trial to diagnose MVO and a randomized controlled trial to evaluate therapeutic treatments for MVO through the CoFI system
BAAR, Switzerland–(BUSINESS WIRE)– CorFlow Therapeutics AG (CorFlow) announced today that it has raised €44 million in Series B funding, co-led by Broadview Ventures and Panakes Partners with strong continued support from 415 Capital, CorFlow’s initial VC investor and largest shareholder. Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital participated in the multinational syndicate.
Concurrent with the financing, David Prim of Broadview Ventures, Barbara Castellano of Panakes Partners, Yoann Bonnamour of Merieux Equity Partners, and Rhiya Pau of Laerdal Million Lives Fund have joined the CorFlow Board of Directors.
The Series B will fund the MOCA II (MVO with CoFITM System Assessment II) pivotal study intended to gain US market clearance. The trial will run in the US and Europe and aims to validate CorFlow’s CoFl system to diagnose MVO in heart attack patients immediately following stent implantation. Additionally, it will fund an adaptive platform therapy study evaluating treatment effects of therapeutic agents delivered locally through the CoFl system on heart attack patients diagnosed with MVO.
MVO affects more than half of all patients who suffer an acute heart attack and is an independent predictor for heart failure and mortality. Currently not routinely diagnosed MVO remains largely untreated, leading to poor patient outcomes, and contributing to high health care costs associated with cardiovascular disease.
CorFlow’s CoFl system is being developed to provide timely, accurate and consistent detection of MVO while patients are still in the catheter laboratory (cath lab) immediately following reopening of the larger epicardial arteries with a stent. Uniquely, the technology has been designed to also enable localized delivery of therapeutics to the microvasculature upon MVO diagnosis. CoFl also seamlessly integrates into standard workflows utilizing existing guide catheter and wire access.
“We are thrilled to have closed on this significant round of financing, backed by a top-tier global syndicate of medical technology investors,” commented Paul Mead, President and Chief Executive Officer of CorFlow. “Recent data from over 70 patients in our MOCA I first in human trial and from our extensive preclinical program support our collective confidence that we can improve outcomes in patients who suffer heart attacks, specifically those patients whose microvascular disease goes undiagnosed and untreated today. There is overwhelming evidence now that microvascular conditions are a significant root cause of adverse outcomes in heart attack patients and other cardiovascular conditions. I am grateful that our new investors have the vision to see ‘where the puck is going’ in this rapidly emerging field.”
The MOCA II IDE trial is designed to confirm the CoFl system’s accuracy in diagnosing MVO in high-risk heart attack patients. Led by Principal Investigator Dr. Tim Henry of The Christ Hospital in Cincinnati, Ohio, the trial will recruit several hundred patients undergoing stent implantation due to ST-Elevation Myocardial Infarction (STEMI) and will compare CoFl’s proprietary dynamic diagnostic measurement of MVO to post-procedure Contrast Enhanced Cardiac Magnetic Resonance Imaging (CMRI), the current gold standard for detecting MVO. The MOCA II trial leverages the learnings from the company’s First-In-Human MOCA I trial conducted in Switzerland, Lativa and the UK.
“There is increasing awareness of the impact of MVO on patient outcomes following coronary revascularization. CorFlow has the potential to be the next significant breakthrough in treating coronary artery disease, and Broadview is delighted to be supporting this impressive team and technology,” states David Prim of Broadview Ventures.
“CorFlow’s breakthrough technology has been designed by clinicians for clinicians and we are excited to support CorFlow’s mission to generate robust clinical data in order to get this much needed therapy to the patient as quickly as possible.” adds Barbara Castellano of Panakes Partners. “We also are committed to supporting the emerging field of microvascular disease in general, and this oversubscribed funding round gives us options to apply the technology in new ways, and in new geographies, where patients can benefit.”
The funding will also support a novel adaptive platform therapy trial in Europe evaluating whether localized delivery of therapeutics to the microvasculature immediately following stent implantation can improve outcomes in patients diagnosed with MVO. Led by Dr. Giovanni Luigi De Maria (Oxford University Hospitals Trust, UK) and Professor Colin Berry (University of Glasgow and NHS Golden Jubilee National Hospital, UK), this European RCT will assess the effects of several therapeutic agents with both clinical and imaging measures up to six months.
“The improvement in outcomes for heart attack patients has stagnated over many years now and we believe that real-time diagnosis and targeted therapy for MVO has the potential to save the lives of countless patients in the future.” comments Frederik Groenewegen of 415 Capital. “We have long been believers in the CorFlow technology and team, and with the support of this first-class investor syndicate we now have the opportunity to collect the clinical data required to establish a new standard of heart attack care.”
About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with offices in Italy, and founded in 2016 by Dr. Rob Schwartz, Dr. Martin Rothman and Jon Hoem. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications in and beyond the heart.
About Microvascular Obstruction (MVO): Often described as the “last frontier” in the treatment of acute heart attacks, MVO is characterized by blockages in the microvascular coronary arteries, which vary in size down to the circumference of a human hair. Previous research has identified that MVO is one of the most powerful prognostic indicators for future adverse outcomes – for every 1% increase in MVO, there’s a corresponding 14% increase in one-year mortality risk and 8% increase in hospitalization due to heart failure.
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CorFlow Therapeutics AG