De-Risk and Execute to Create Value

Key Learnings From Nitin's Experience

• Developing novel technology without predicates carries clinical risk. On the other hand, improving existing tech, or creating a next-gen device, comes with technical and/or commercial risk. Therefore, decide which risks you want to tackle and prioritize them appropriately to avoid overwhelm. 

• Create value that resonates with all stakeholders—patients, physicians, and investors. Address risks step by step, keeping value creation at the core of every decision. If you can, choose clinical paths that give you more options, demonstrate progress, and use data to build credibility and attract investment.

• Start with a clear end goal and focus on creating value that aligns with the needs of your customers, strategics, and investors. Be efficient with capital by ensuring your returns far outweigh your cash burn. Build trust and prove your ability to execute by consistently hitting milestones and keeping stakeholders informed. And don’t hesitate to engage with strategics—you can’t expect to come out of stealth and suddenly be a priority for acquirers.

Nitin Salunke holds a PhD in Mechanical Engineering and is an inventor and co-author on many patents and publications. Prior to Supira, he was Vice President of R&D at Medtronic Neurovascular, overseeing global product development and playing an instrumental role in building the neurovascular stroke portfolio, reaching $1B revenue milestone. Nitin has also held leadership roles at Altura Medical, Cordis Corp (then, a Johnson & Johnson company), and W.L. Gore & Associates, where he helped the company transition from a surgical vascular graft business to an endovascular enterprise.

Supira Medical was founded within the Shifamed innovation hub in 2018. Nitin joined the company as CEO about a year after its founding. The timing might have presented a challenge—just a month in, COVID-19 disrupted everyday life—but Nitin has successfully led the company through several key milestones.

Supira’s device aims to tackle two significant challenges in cardiovascular care: provide hemodynamic support during high-risk percutaneous coronary interventions (PCI) and support patients with cardiogenic shock (aka; severe heart failure) to recover the native heart or as a bridge to heart replacement.

In 2023, Supira raised a $40 million Series D and announced that it has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Supira System, a next-generation percutaneous ventricular assist device (pVAD). The company has active clinical evaluations in South America and the United States. The U.S. early feasibility study will enroll 15 patients and aims to pave the company’s path toward a pivotal trial and subsequent commercialization following FDA approval.