UroMems Raises Record $47 million (€44 Million) in Series C Financing to Fund Pivotal Clinical Trials of the UroActive™ System, the First Smart Automated Implant to Treat Stress Urinary Incontinence
UroMems Raises Record $47 million (€44 Million) in Series C Financing to Fund Pivotal Clinical Trials of the UroActive™ System, the First Smart Automated Implant to Treat Stress Urinary Incontinence
GRENOBLE, France & MINNEAPOLIS, Minnesota (June 25, 2024) – UroMems, a global company developing innovative, implantable mechatronics technology to treat stress urinary incontinence (SUI), today announced it has raised $47 million in its Series C financing, the largest fundraising round to date for the company. The capital will support large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI.
The financing round was led by Crédit Mutuel Innovation and joined by the European Innovation Council as well as the existing investors Wellington Partners, Bpifrance, Supernova Invest, Hil-Invent, b-to-v Partners and Financière Arbevel.
“We are thrilled to lead this record round for UroMems,” said Jérôme Feraud, Head of Health Division at Crédit Mutuel Innovation. “Based on very positive data and feedback from patients and physicians in the pilot clinical trials, we strongly believe that the UroActive smart implant has the potential to become the standard of care as the next-generation SUI treatment.”
Under the strong and steady leadership, energy and guidance of co-founders Chief Executive Officer Hamid Lamraoui and Chief Medical Officer Professor Pierre Mozer, UroMems has successfully surpassed critical milestones in research and development, clinical outcomes and building the organization. The funding comes on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and successful six-month primary endpoint for the first-ever female patient to receive the UroActive System. For all study patients the devices are operating as expected for over one year now with no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.
“We’ve invested in UroMems from the start and our confidence that the UroActive System will improve patients’ lives continues to grow as the company reaches one major milestone after the other,” said Dr. Johannes Fischer, Partner at Wellington Partners. “We look forward to continue supporting the company as they move closer to bringing this promising technology to both women and men suffering from SUI.”
“On behalf of our entire exceptional team and the patients whose lives have been restored thanks to our technology, we are grateful to our investor partners for their continued support as we approach the critical milestone of launching our pivotal clinical trial,” said Lamraoui. “The confidence of our new and existing investors combined with the strength of our compelling results and tremendous physician interest shows the high potential of our technology. This brings us one step closer to delivering on the massive unmet need for men, 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. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low selfesteem and social stigma.
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 150 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeonconvenience. 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
Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors
Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors
Fast Track designation highlights potential for CT-0525 to address unmet need for patients with solid tumors
Initial Phase 1 data expected by year-end 2024
PHILADELPHIA, June 25, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an 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).
The FDA’s Fast Track program is aimed to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant unmet medical need.
“Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA’s recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need,” said Eugene P. Kennedy, M.D., Chief Medical Officer of Carisma. “We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024.”
The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525. This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06254807.
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 macrophage therapy.
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, the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 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.
Investors:
Shveta Dighe
Head of Investor Relations
Media Contact:
Julia Stern
(763) 350-5223
