Participated · Series C · Sep 2022

JenaValve designs, develops and commercializes the Trilogy Heart Valve System, a TAVR platform intended to treat symptomatic, severe aortic regurgitation (AR) and aortic stenosis (AS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021 and is positioned as a dual‑disease treatment device. The company has received FDA Breakthrough Device Designation for ALIGN-AR to facilitate review of a pivotal U.S. trial as part of a PMA filing. JenaValve intends to use its recent financing to complete an IDE/PMA study to obtain FDA approval for Trilogy in AR patients. Proceeds will also support real‑world data development in Europe and expansion of worldwide manufacturing capabilities. The company is led by CEO John Kilcoyne and operates locations in Irvine, CA, Leeds, U.K., and Munich, Germany. JenaValve Technology develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems, including the Trilogy® TAVR system. The Trilogy system is intended to treat patients with severe symptomatic aortic regurgitation (AR) and aortic stenosis (AS). JenaValve is conducting the ALIGN-AR PMA clinical trial (IDE approved August 2021) and reports patient enrollment remains on track as it pursues U.S. FDA approval for the Trilogy Heart Valve System. The company said the capital from the new partnership will support the ALIGN-AR trial and accelerate expansion of its current commercial activities in Europe. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany. Existing backers include Bain Capital Life Sciences, Cormorant Asset Management, Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, VI Partners and Peijia Medical. JenaValve develops the JenaValve Pericardial TAVR System, a self‑expanding nitinol stent with a porcine pericardial valve available in three sizes. The device is investigational and not available for sale in the U.S. or internationally. The company is conducting a global multicenter clinical program targeting severe aortic regurgitation (AR) and AR‑dominant mixed aortic valve disease in high‑risk surgical patients. JenaValve recently received Breakthrough Device designation from the U.S. FDA, which allows priority review of its Align Clinical Trial. Following completion of the Humanitarian Device Exemption (HDE) portion of the trial, enrollment will continue to support a Premarket Approval (PMA) submission under the Breakthrough program. The company also anticipates filing for CE mark approval for both aortic stenosis and aortic regurgitation in the second half of 2020. JenaValve Technology develops, manufactures and markets next-generation transcatheter aortic valve repair (TAVR) systems to treat patients with aortic valve disease. Its Transapical TAVR system (JenaValve valve plus Cathlete PLUS delivery) has CE Mark approval for aortic stenosis and the unique indication to treat aortic valve insufficiency. The company currently markets this product in Europe and selected markets worldwide and has operating locations in Munich, Germany and Irvine, California. JenaValve completed a $26.5 million Series C expansion financing to fund further growth in the global TAVR market. Proceeds will support key clinical studies required to gain European regulatory approval and to complete a U.S. feasibility study for a new aortic valve and transfemoral delivery system. The financing is positioned to help JenaValve advance its product pipeline and execute regulatory and clinical plans. JenaValve Technology develops, manufactures and markets transcatheter aortic valve implantation (TAVI) systems, including a CE‑marked transapical TAVI system currently sold in Europe and other markets. Its JenaValve prosthesis pairs a porcine bioprosthesis with a Nitinol self‑expanding stent and features a “3‑feeler element” for accurate positioning plus a JenaClip anchoring mechanism; the valve is retrievable and repositionable and implanted on the beating heart. The company’s transfemoral TAVI system entered a first‑in‑man clinical study at the end of 2013 and was anticipated to be commercially available in 2015. JenaValve positions its devices as second‑generation TAVI products aimed at easing implantation and reducing pacemaker implantation and paravalvular leakage. Financially, the company expanded its Series C by $10 million, bringing the round total to $72.5 million. JenaValve is a U.S. corporation with primary operations in Munich and was founded by cardiologists Prof. Hans R. Figulla and Prof. Markus Ferrari.

Led · Series B · Sep 2017

FEops develops FEops HEARTguide, a cloud-based procedure planning environment that combines digital twin technology and artificial intelligence to model interactions between transcatheter structural heart devices and patient anatomy. The platform is CE-marked under MDR for TAVI and LAA workflows and FDA-cleared for the LAA workflow. FEops HEARTguide has been used for over 6,200 patients across 310 hospitals in 27 countries, and provides automated measurements and insights to improve procedure efficiency and clinical outcomes. The company says clinical data from the PREDICT-LAA randomized controlled trial show significant improvements in efficiency and outcomes for LAA occlusion procedures. FEops plans to expand its established digital twin technology into other indications and continue scaling its commercial and clinical footprint. The company is supported by Valiance Advisors, Capricorn Partners, PMV and the EIC Fund. FEops develops FEops HEARTguide, a cloud-based procedure planning environment that uses personalized computational modeling and simulation to predict interactions between transcatheter structural heart devices and patient anatomy. The current release includes workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAO). FEops HEARTguide received CE mark and approval for the Canadian market earlier this year. The company says it will use the Euro 3.2 million EIC grant to accelerate clinical evidence gathering, business implementation worldwide, and to extend device certifications. FEops is privately held and headquartered in Gent, Belgium, and its leadership includes co‑founder and CEO Matthieu De Beule and CFO Isabelle Decroos. In September 2017 FEops closed a €6 million financing led by Valiance with participation from Capricorn Venture Partners and PMV. FEops develops personalized computer simulations to improve structural heart interventions, focused on transcatheter valve therapies. Led by co-founder and CEO Matthieu De Beule, Ph.D., the company’s core product family is FEops HEARTguideTM. Its first product, TAVIguide™, is currently the only CE-marked technology that predicts how a TAVI implant will interact with patient-specific aortic anatomy and provides clinically meaningful insights for personalized device size selection and position. FEops’ proprietary system aims to improve procedural planning and outcomes for transcatheter valve procedures. The company intends to use recent funding to accelerate its product roadmap centered on FEops HEARTguide and to drive commercial adoption in the transcatheter valve market. Financial details of the fundraise are provided in the deal summary.

Participated · Series D · Aug 2017

NeoSync, based in Boston, MA, is a clinical-stage company developing NEST®, its proprietary non-invasive neuromodulation platform for Major Depressive Disorder and other CNS diseases. NEST (NeoSync-EEG Synchronized TMS) delivers low-energy, alternating magnetic field stimulation in daily 30-minute sessions that are personalized to a patient’s individual alpha brain frequency as measured by a brief EEG. The company is led by President and CEO Kate Rumrill. NeoSync completed a $13M Series D financing. The company intends to use the funds to support a planned registration study of NEST in patients with treatment-resistant depression (TRD) and to prepare for future commercial release. The technology positions synchronized TMS (sTMS) as a gentle, personalized neuromodulation approach.

Led · Series B · Mar 2016

4Tech Inc. is a privately held medical device company that developed the TriCinch™ system, described as the world’s first transcatheter device to treat tricuspid regurgitation (TR). The TriCinch™ system uses a unique anchoring and tensioning mechanism to enable a simple and reproducible percutaneous repair of the tricuspid valve. TR affects approximately three million people in the U.S. and Europe, is typically managed with diuretics, and surgical intervention is considered very high‑risk, leading to frequent rehospitalizations and high costs. 4Tech positions the device to reduce TR, restore patient quality of life, and potentially deliver substantial healthcare cost‑savings. The company is incorporated in Delaware and operates in Galway, Ireland (4Tech Cardio Ltd). The TriCinch™ system is in an early phase of development, is not available for sale, and is not available for U.S. clinical trials at this time. Proceeds from the recent financing will be used to secure European market entry for the TriCinch™ system.

Participated · Series E · Nov 2013

Biocartis develops Idylla, a miniaturized, fully automated molecular system that integrates all molecular diagnostics steps and delivers results in 35–120 minutes; the system and its first assay have CE‑IVD marking. The company plans to use the new capital to fund the commercial roll-out of Idylla in Europe later this year and to expand commercial reach beyond Europe next year. Proceeds will also support and accelerate development of a broad assay menu across oncology, infectious diseases and other applications. With the EUR 64.5 million equity round, total capital invested in Biocartis to date amounts to EUR 240 million (approx. USD 316 million). Biocartis has separated its Evalution business unit and combined it with Pronota to form MyCartis, which will continue biomarker panel development in Ghent and maintain activities in Switzerland. The Evalution platform (previously DMAT) is positioned as a molecular biomarker multiplexing technology for clinical and pharmaceutical applications. Biocartis is developing the Idylla molecular diagnostics platform and a range of assays with an initial focus on oncology. It completed a EUR 30 million Series E equity fundraising to validate Idylla and its first assay and to continue assay development. The round was entirely subscribed by existing shareholders such as RMM (Rudi Mariën), Debiopharm Diagnostics SA, PMV Tina Fund, Valiance, Johnson & Johnson Development Corporation, Philips, the Wellcome Trust, Petercam, the family offices of Dr. Paul Janssen, Luc Verelst, Rudi Pauwels, and some smaller shareholders including employees. Biocartis said the funding positions it to unroll an ambitious commercialization plan in 2014 and expects to launch the Idylla platform and a BRAF cancer assay in the second half of 2014. Idylla is described as a compact, scalable platform that allows assays to be performed anywhere without a specialist laboratory or trained technicians, rapidly detecting biomarkers with higher sensitivity than standard diagnostic assays and sequencing. Management signalled a goal of becoming a fully integrated global diagnostics company and will use the proceeds to advance validation, assay development, and commercial preparation. Biocartis develops clinically relevant molecular diagnostic tests and easy-to-use, fully automated platforms with a primary focus on oncology. The company will use a 1.9M subsidy from the Belgian Agency for Innovation by Science and Technology (IWT) to accelerate a two-year project to develop new cancer assays. The planned tests will detect known, validated oncogenes and focus on skin, colon and lung cancers to enable more targeted treatment. Biocartis will also create assays that permit simultaneous detection of dozens of parameters for its recently launched multiplex detection platform aimed at the research market. Founded in 2007 and based at EPFL’s Innovation Square in Lausanne, the company has fully owned subsidiaries in Mechelen (Belgium) and Eindhoven (Netherlands). Biocartis employs over 150 people and has raised close to EUR 150 million in equity to date. Biocartis is a Lausanne, Switzerland-based molecular diagnostics company that develops and commercializes diagnostic platforms and clinically relevant oncology assays. Its core product effort includes the Apollo platform, which the company intends to validate, register and launch. The company plans to continue developing its oncology tests and to grow its commercial presence. Biocartis completed a €34.5m (approximately $45m, CHF 42m) Series D equity funding to support those efforts. As part of the financing, Roald Borré, representing the lead investor PMV, will join Biocartis’ board. The company is led by CEO Greg Parekh and chairman and founder Rudi Pauwels. Biocartis develops and commercializes compact molecular diagnostic systems and completed a €71m (US$100m) Series C equity financing. The company intends to use the funds to commercialize its first product and other diagnostic applications. Biocartis will launch its first system, Apollo, in 2013; Apollo was developed in close collaboration with Philips Corporate Technologies to enable personalized medicine and individual diagnoses. Apollo is a compact system that allows multiple assays to be performed anywhere, rapidly and without the need for a specialist laboratory environment or trained technicians. Founded in 2007 and based in Lausanne, Switzerland, Biocartis also operates a fully owned Belgian subsidiary in Mechelen and a Dutch subsidiary at the High Tech Campus in Eindhoven. Following the fundraise, the company plans to enlarge its Board and adjust its membership.