Insightec spins out Lotus Neuro to advance brain therapies that tackle ‘a huge unmet need’

For Insightec, its decision to spin out a new entity marks a significant inflection point not only for the global medical technology company, but for the broader field of brain medicine — as well as for Miami’s growing medtech and biotech ecosystem.

Announced today, the launch of Lotus Neuro creates a new Miami-based clinical-stage biotechnology company dedicated to advancing brain-targeted therapies that use low-intensity focused ultrasound to safely and temporarily open the blood-brain barrier. The spin-out formalizes a strategic shift that Insightec leaders say has been built on a foundation of clinical validation, global adoption, and rising interest from pharmaceutical and biotech partners.

“The science is there. The clinicals are there,” said Maurice R. Ferré [pictured above], chairman and CEO of Insightec, in an interview with Refresh Miami. “We have such amazing technology, and we can make a difference. We have to move fast — and that’s what we’re doing.”

Insightec, based in Miami and Haifa, Israel, is best known for its Exablate Neuro platform, an incisionless, MRI-guided focused ultrasound technology already used to treat more than 25,000 patients worldwide for movement disorders such as essential tremor and Parkinson’s disease. With systems installed at more than 210 centers globally, including every top U.S. neuroscience department, the company has firmly established focused ultrasound as a must-have tool in modern neurosurgery.

Over the past several years, Insightec also has quietly amassed a substantial body of clinical evidence showing that low-intensity focused ultrasound can be used to open the blood-brain barrier and dramatically improve the delivery of drugs that would otherwise never reach diseased brain tissue. To date, the platform has been used in nearly 600 therapeutic cycles across indications ranging from brain tumors to Alzheimer’s, Parkinson’s disease, and ALS.

The big opportunity for Lotus Neuro is to make effective, brain-targeted therapies a reality by uniting the right therapeutics, the right biology and the right indications with this technology, said Arjun “JJ” Desai, MD, the newly appointed CEO of Lotus Neuro.

“It’s incredibly meaningful. There’s a huge unmet need for patients,” Desai said. “It’s an opportunity we must pursue. We owe it to patients and our community of clinicians and scientists,” Desai said.

Arjun “JJ’ Desai, CEO of Lotus Neuro

Desai previously served as Insightec’s chief strategic innovation officer, where he built global market access, medical affairs, and pharmaceutical partnership functions that ultimately helped lay the groundwork for the Lotus Neuro spin-out. Before that, Desai was involved with several medtech startups.

Lotus Neuro will initially focus on neuro-oncology, including glioblastoma and diffuse midline gliomas, while advancing preclinical programs in neurodegeneration. The approach builds directly on Insightec’s recent momentum, including a multicenter glioblastoma trial published in The Lancet Oncology that showed significantly improved overall survival when focused ultrasound was used to open the blood-brain barrier during chemotherapy.

Ferré believes this work could ultimately reshape how devastating brain diseases are treated. “I really think we have a pathway for brain cancer that Lotus and JJ are going to be working on, that I think it’s going to change the whole paradigm,” he said. They don’t have to be a death sentence, but rather a disease that you can manage. “I think we’re the cusp of that.”

For Insightec, the creation of Lotus Neuro allows each organization to do what it does best: Insightec will continue scaling its device platform globally, while Lotus focuses on pairing that platform with next-generation therapeutics. Together, they are betting that precision ultrasound can unlock a new era of brain medicine — one that delivers hope to patients who have long had too few options. “Together we are a complete ecosystem, from device to drug delivery, to change what’s possible in neuroscience.” Ferré said. “And there’s a lot more to come.”

The new company is funded by Nexus NeuroTech Ventures, and more details about the team and next steps will be announced in coming months, Desai said.

The spin-out news highlights Miami’s growing role as a hub for medtech and life sciences. Both Insightec and Lotus Neuro are headquartered in Miami, and both leaders see the city as an increasingly competitive environment for building global healthcare companies.

Desai said when he moved here from San Francisco 12 years ago, biotech wasn’t really part of the conversation. Now we have the ecosystem with the talent, the capital, the clinical institutions and the lifestyle that attracts people to stay and build, he said.

Ferré echoed that view, pointing to the University of Miami, Baptist Health’s Miami Cancer Institute, and expanding private and public research funding as key ingredients. Recruiting has become easier too.  “Miami has the right to win in life science and medtech,” he said, “and Lotus is another example of what can spin out of our ecosystem.”

Insightec’s Exablate.

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Nancy Dahlberg