The Venture Codex

Participated · Equity · Aug 2025

Orchestra BioMed focuses on late-stage device-based cardiology programs, notably AVIM therapy for uncontrolled hypertension in pacemaker-indicated patients and Virtue SAB for coronary artery disease. The company advances technologies through partnership-driven, royalty-based collaborations to accelerate patient access while preserving capital efficiency. Orchestra has an ongoing strategic collaboration with Medtronic to develop AVIM therapy and has amended that agreement to include potential integration into leadless pacemaker systems. Recent financing activity from strategic investors is intended to fund late-stage clinical and development milestones for these programs. Financial arrangements announced include equity/private placement components, a secured subordinated promissory note that can convert to a prepaid revenue share, and royalty commitments to a strategic investor. The transactions are structured to provide near-term capital and align future commercial economics with partners and investors. Orchestra BioMed develops partnered medical device therapies and advances them via strategic collaborations with large medtech companies. Its flagship candidates are BackBeat Cardiac Neuromodulation Therapy (CNT) for lowering blood pressure in patients indicated for pacemakers and Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) for certain artery disease indications. BackBeat CNT produced statistically significant reductions in 24-hour ambulatory and office systolic blood pressure in the MODERATO II pilot, and Orchestra plans a global pivotal trial in collaboration with Medtronic. The company has a strategic collaboration with Medtronic for development and commercialization of BackBeat CNT (with revenue sharing) and a partnership with Terumo for Virtue SAB (including a $30 million upfront payment and potential milestone payments). Orchestra closed a $110 million Series D and, together with a planned business combination with HSAC2 and supporting forward-purchase and backstop commitments, expects pro forma gross proceeds sufficient to fund operations into 2026; it also has conditional access to up to $40 million in term debt. The combined company is planned to list on Nasdaq under the ticker OBIO and will use proceeds to support pivotal trials scheduled to initiate in 2023 and to expand its partnership-enabled product pipeline. Orchestra BioMed is a biomedical innovation company providing high‑impact solutions for large unmet needs in procedure‑based medicine. Its pipeline includes Virtue® Sirolimus‑Eluting Balloon (SEB) for coronary and peripheral interventions and the Moderato® implantable pulse generator that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for hypertension. The company announced CE mark approval for Moderato in September 2019 and Virtue SEB received FDA Breakthrough Designations for coronary in‑stent restenosis and below‑the‑knee peripheral artery disease. Orchestra BioMed presented late‑breaking TCT 2019 clinical results showing BackBeat CNT drove a statistically significant and clinically meaningful reduction in 24‑hour ambulatory systolic blood pressure versus control. The company pursues strategic partnerships to commercialize products and recently entered a global strategic partnership with Terumo Corporation for development and commercialization of Virtue SEB. Financially, Orchestra BioMed completed a $34 million financing in July 2019 and has added a $20 million credit facility to accelerate pipeline development and support general corporate purposes. The company states its business model aims to optimize capital efficiency and cash flow while advancing product development and commercialization. Orchestra BioMed develops procedure-based medical-device therapies with a focus on high-impact unmet needs; its lead assets are Virtue SEB for artery disease and BackBeat CNT for hypertension. The company has a global strategic partnership with Terumo to develop and commercialize Virtue SEB, which received FDA Breakthrough Device Designation for coronary in‑stent restenosis in April 2019 and is planned for a U.S. registrational IDE trial within the next year. BackBeat CNT recently completed enrollment in a randomized clinical study and is on track to report six‑month data later in the year. In 2019 the company secured $64 million in capital inflows, including a $30 million up‑front payment from the Terumo partnership, and completed a $34 million Series B‑1 financing to accelerate pipeline development. Orchestra intends to use proceeds to expand development of Virtue SEB and BackBeat CNT, pursue additional global clinical studies, and develop additional sustained‑release sirolimus product candidates in other procedure‑based markets. The company also continues to evaluate selective product acquisitions and licensing opportunities and relies on partnerships with established commercial leaders to drive global commercialization. Orchestra BioMed is a biomedical innovation company based in New Hope, PA, focused on evidence-based therapeutic solutions addressing major unmet medical needs, with a primary focus on cardiovascular disease. The company’s core product development expertise spans drug delivery, interventional devices, bioelectronics and neuromodulation. Its lead product candidates are the Virtue® Sirolimus-Eluting Balloon (SEB), a drug-eluting angioplasty balloon that delivers delayed-release bioabsorbable particle-encapsulated sirolimus, and BackBeat® Cardiac Neuromodulation Therapy (CNT), a patented implantable neuromodulation treatment for hypertension. Orchestra closed a $41M equity financing that included conversion of outstanding debt to equity and a financing structure providing for up to an additional $23M in follow-on financing from existing investors. The company intends to use the funds for continued late-stage clinical development of Virtue SEB and BackBeat CNT. Orchestra also holds a wholly owned subsidiary, FreeHold Surgical®, and significant minority interests in Motus GI® Holdings, Inc. (MOTS) and Vivasure Medical Ltd., which are advancing commercial launches of their respective products.

Participated · Series C · May 2020

Palvella Therapeutics focuses on developing and commercializing novel therapies for serious, rare genetic skin diseases that currently lack FDA-approved treatments. The company advances a broad pipeline built on its patented QTORIN platform, initially targeting lifelong rare skin disorders. Palvella works with patient advocacy organizations and patient registries to design accelerated development programs to expedite patient access to targeted therapies. Its lead product candidate is QTORIN 3.9% rapamycin anhydrous gel, being developed for pachyonychia congenita, microcystic lymphatic malformations, and prevention of basal cell carcinomas in Gorlin syndrome. QTORIN rapamycin has received FDA Fast Track Designation for all three indications. The company recently completed a Series D financing to support advancement of QTORIN rapamycin across these indications. Palvella Therapeutics is a Wayne, PA–based rare disease biopharmaceutical company focused on developing and commercializing pathogenetically targeted therapies for serious genetic diseases with no approved treatments. Its lead program, PTX-022 (QTORIN™ 3.9% rapamycin anhydrous gel), is in a Phase 2/3 pivotal study for pachyonychia congenita (PC), a rare, chronically debilitating and lifelong genetic disease estimated to affect more than 9,000 individuals in the U.S. The company partners with patient advocacy organizations and patient registries to design fit-for-purpose, accelerated clinical development programs aimed at expediting targeted therapies to patients lacking approved options. Palvella intends to use the proceeds from the financing to advance PTX-022 in adults with PC. Wes Kaupinen serves as President and CEO. In conjunction with the funding, Scott Morenstein of CAM Capital and Cory Freedland of Samsara BioCapital joined Palvella’s Board of Directors. Palvella Therapeutics is a Wayne, PA-based rare disease biopharmaceutical company focused on developing and commercializing pathogenetically targeted therapies for debilitating, rare genetic diseases with no approved treatments. The company is led by Wes Kaupinen, president and chief executive officer. Its lead program, PTX-022 (QTORIN™ rapamycin formulation), is entering Phase 2/3 development for pachyonychia congenita (PC). PC is a rare, chronically debilitating lifelong monogenic disease in which mutations in keratin genes lead to dysregulated keratinocyte proliferation, increased skin fragility and impaired plantar skin barrier function. Palvella will continue to retain responsibility for all clinical development, regulatory, manufacturing, marketing and other commercialization activities worldwide. The company has secured external development funding to advance PTX-022.

Led · Equity · Feb 2019

Dianomi Therapeutics is advancing a proprietary Mineral Coated Microparticle (MCM) platform designed to mimic mineralized tissues to preserve and provide controlled release of drug molecules without loss of function. The MCM technology is manufactured from generally recognized as safe (GRAS) materials in a scalable process, with properties that can be tailored to specific drugs and applications. Dianomi’s initial focus is on creating novel formulations of existing biologics and small molecules to treat inflammatory diseases, notably osteoarthritis and pain. The MCM platform was developed in the laboratory of William Murphy, Ph.D., and is patented under the Wisconsin Alumni Research Foundation with issued patent coverage through 2037. Leadership includes Barry Kurokawa as CEO and co-founder and William Murphy as Chief Scientific Officer and co-founder. Financially, Dianomi received a $3 million investment from Ligand Pharmaceuticals that includes a loan component convertible into $1 million of equity and attached royalty rights.