The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation for the first time is also inviting outside companies to use its resources.
Founded in 1985, the Valencia-Calif.–based foundation has launched several innovative companies, including Second Sight Medical Products (NSDQ:EYES), which makes devices for the visually impaired; cochlear implant manufacturer Advanced Bionics, now a subsidiary of Sonova Holding AG (SIX:SOON); and MiniMed, developer of a hybrid closed-loop insulin delivery system, now part of Medtronic (NYSE:MDT).
“It was essentially an incubator before the term ‘incubator’ even existed,” said Dr. Robert Greenberg, who took over as executive chairman in June 2018 after serving as non-executive chairman since 2004. (John Petrovich leads AMF as its CEO.)
“This infrastructure of laboratory space and technical talent and equipment and expertise – regulatory and quality in the manufacturing of these devices – the core expertise ended up being leveraged each time a new company was developed. A lot of that built-up knowledge… has really benefited each new startup,” Greenberg said.
Greenberg was CEO and chairman of Second Sight from its inception in 1998 through 2015. Second Sight developed and marketed an implantable retinal prosthesis, the Argus II, to restore useful vision to patients blinded by retinitis pigmentosa. Greenberg also oversaw the successful development and human implantation of a wireless cortical visual prosthesis, the Orion, which the company says has the potential to eliminate nearly all forms of blindness.
Every project the foundation undertakes must be designed for a high unmet medical need, either to help a large number of people or to provide a high impact for a small group of people, such as amputees. Deciding which projects to take on remains one of its biggest challenges.
“We look at IP, what patents we might have or might be able to license, as well as freedom to operate,” Greenberg said. “We’ll look at market size, reimbursement, team ability to access folks with expertise in the area – all the factors that you would look at for a startup.”
In his new role, Greenberg has encouraged incubating local companies in addition to internal projects. He likes to think about the foundation as a research institution with a commercialization focus. Greenberg shares the belief of the foundation’s founder, the late Al Mann, that unless the products actually make it to a company, they won’t benefit patients.
“One of the realizations that I had about a year ago was that this infrastructure can be super-helpful to startups that might only have half a dozen people,” he said. “We started working with local companies, providing them access to the labs, to the personnel, and to the infrastructure in general. As far as picking those companies, our criteria are similar to picking our own internal projects.”
They include BiVACOR, a Houston, Texas startup that is developing a completely artificial heart using two centrifugal impellers placed on a single rotor to provide perfusion to the left and right sides of the body. The device uses magnetic levitation to provide precise, stable operation with no mechanical wear. It is currently being tested in animal trials.
“Although our ultimate goal is to help these individuals and patients with these various diseases, we feel really strongly that these products ultimately need to find a home in a company so that they can be distributed for the benefit of patients,” Greenberg said.
The foundation’s financial resources and accumulated knowledge enable it to stick with projects for the long-term, and allow the companies it develops to be more capital-efficient and to make fewer mistakes, Greenberg said.
Mann was a leader in the aerospace industry when he made a donation to Johns Hopkins University’s applied physics laboratory to develop a rechargeable pacemaker in 1968. The following year, at the university’s request, Mann took over the product’s development, co-founding Pacesetter Systems with Johns Hopkins researcher Robert Fischell.
Pacesetter was purchased by Siemens in 1985 (and later, by St. Jude Medical), and Mann used some of the proceeds to start the foundation to convert university-based research into products that filled unmet and poorly-met medical needs.
A more recent foundation-based startup, Axonics Modulation Technologies (NSDQ:AXNX), went public in October, raising $138 million in its IPO. The Irvine, Calif.–based company is developing novel, implantable sacral nerve neuromodulation tech to treat patients with urinary and bowel dysfunction disorders, with hopes that the platform will be expandable into other clinical indications in the future.
Axonics’ r-SNM device won CE Mark approval in the European Union in June 2016; an external trial module won an FDA nod in July 2017. It’s approved for market in Canada and Australia and expects to file a pre-market approval bid with the FDA during the first quarter of 2019.
Now the foundation is working on an implantable myoelectric (IME) sensor, a matchstick-sized device designed to transmit electrochemical signals from muscles in the residual limb of an amputee to intuitively move a prosthesis. A controller interprets the signals and commands the prosthesis to perform a particular movement, such as opening and closing the hand, rotating the wrist 360 degrees and laterally moving the thumb.
Combining these three movements enables several grasps that are invaluable for performing everyday tasks, according to the foundation. Veterans at the Walter Reed National Military Medical Center are participating in a clinical trial of the sensor, and the foundation expects to transfer the technology to a corporation in 2019, Greenberg said.
“I think medtech is one of the most exciting areas that you can go into in engineering in general,” Greenberg said. “We’re looking a lot more at digital health solutions. We’re looking at how artificial intelligence and data can play a role in medical devices. It’s something that, historically, we had a lot of implants that were generating data but we weren’t necessarily using that data. We’re spending a lot more time now looking at, particularly (with) our implants, we’re thinking a lot more about the data and how that can be leveraged for the benefit of patients.”