There’s a promising new treatment for asthma that isn’t a drug or biologic.
A new Irvine-based company called Spiro Medical believes the future of asthma care is in neuromodulation and is developing an implantable device to treat severe asthma.
The company’s chairman is well-known in the field: Raymond Cohen, co-founder of Axonics, which he sold to Boston Scientific Corp. for $3.7 billion in 2024. Spiro Medical is the latest involvement for Cohen, who has seen several successful company exits during his 40 plus years in healthcare.
“This has never been done before,” Cohen told the Business Journal.
The idea seems to be a hit with investors, too.
Earlier this month, the company closed a $67 million Series A round, with proceeds going toward product development and clinical work needed to obtain premarket approval.
The round, led by Andera Partners, Omega Funds and Sherpa Healthcare Partners, had participation from other venture capital firms, including HSG, Supernova Invest, Northern Light Venture Capital and Hero Inc. Ltd UK.
No Current Device Therapy for Asthma
People with asthma experience what’s called bronchoconstriction, or the tightening of the muscles in the airways.
Spiro Medical is developing a neuromodulation device that delivers electrical signals to nerves that regulate the airways, relaxing the constricted muscles and making it easier to breathe. This technique is also used to treat chronic pain.
There is currently no device-based therapy for asthma, which affects more than 28 million Americans and 300 million people worldwide, according to Spiro Medical Chief Executive Rinda Sama.
“If you look at asthma for time immemorial, it’s inhalers, drugs and some biologics that came out recently,” Sama told the Business Journal.
These biologics, however, only have a 28% remission rate, according to Sama.
Sama began working with Cohen in 2005 as an intern at Irvine-based Cardiac Science Inc., a manufacturer of automatic external defibrillators, where Cohen was CEO.
He’s worked with Cohen ever since, serving as head of product assurance, operations and quality at Vessix Vascular Inc. and chief operating officer of Axonics before both were sold to Boston Scientific.
“I had a front row seat at Axonics to learn all the way from how to start a company to how to raise capital, hire people and surrounding yourself with the best and brightest people,” Sama said.
Spiro Medical’s other co-founder, Dr. Jay Jiang, was also chief technology officer for Axonics for 12 years and holds the same role at the new company.
“The product that we went into the IDE study with at Axonics is the same product we commercialized and treated thousands of patients in year one,” Sama said.
“The intention here is to do the exact same thing: build the product that is at commercial readiness, and get regulatory approval.”
Growing Adoption of Neurostimulation
Spiro Medical’s base technology is similar to Axonics’ sacral neuromodulation devices; the innovative aspect is applying it to now treat asthma, according to Cohen.
“The medical community has finally embraced the notion that it’s the nerves in your body that control many critical functions,” Cohen said.
“If you can change those pathways and normalize then, you can solve a lot of clinical conditions in the body.”
Cohen, who had the vision 13 years ago that neurostimulation could treat urinary incontinence and other bladder issues, said that neuromodulation is now widely used to treat conditions including chronic pain, sleep apnea, Parkinson’s disease and depression.
Cohen retired being a CEO following the Axonics sale to focus on serving as an advisor on the boards of medtech companies.
He was appointed chairman of Israel-based SoniVie Ltd. the same day he completed the Axonics sale to Boston Scientific; the company last March was also sold to Boston Scientific for $600 million.
Also in March, Kestra Medical Technologies Ltd., where Cohen serves as an independent director and chair of the compensation committee, completed a successful IPO, raising $230 million. The Kirkland, Washington-maker of wearable medical devices now has a $1.3 billion market cap (Nasdaq: KMTS). In October, Nalu Medical, where Cohen served as chairman, was sold for $533 million.
Cohen serves on the boards of five other companies, most recently joining the board of Aliso Viejo’s RxSight Inc. last July.
Doctor Developed Idea
Spiro originated from the work of Dr. Stephen Pyles, a doctor in Florida who specializes in chronic pain and who is a co-founder of the company.
Pyles was treating a patient for pain who also happened to have severe asthma when he came up with the idea to use neuromodulation to treat their asthma symptoms.
He used an existing, off-label neurostimulator, leading to “spectacular results,” according to Cohen.
Pyles ended up treating 11 more patients, nine with asthma and two with asthma and COPD, using the same method.
Results from the small, uncontrolled study revealed that patients with just asthma could completely stop taking their medication without adverse effects.
After publishing the data in the Journal of Asthma, Pyles filed and issued the patents and, around last August, approached Sama and Jiang with the business idea, who then pitched the story to Cohen to join the company as chairman.
“We said, ‘Ok, this is an interesting area with some clinical data and a new indication with a big market opportunity,” Sama said.
Upcoming Clinical Trials
The company plans to do two clinical trials.
The first is a feasibility study testing an off-the-shelf product with about 15 enrolled patients, while the second is a pivotal investigational device exemption (IDE) study using the company’s own neuromodulation system.
“We will be enrolling patients, treating them and capturing data to confirm that this therapy indeed works and mitigate any residual risks that we have on the clinical side,” Sama said.
Spiro Medical is targeting four years to get FDA approval, according to Sama.
