Electronic Waveform Lab Inc. makes electrical stimulation devices designed to noninvasively treat pain and help with rehabilitation without drugs. Largely driven by the opioid epidemic, which President Donald Trump declared a public health emergency in October, the company now offers pain device H-Wave over the counter.
“The over-the-counter model offers more options and more marketing opportunities,” said President Ryan Heaney. H-Wave received Food and Drug Administration clearance for over-the-counter use last month. It’s heretofore directed marketing at doctors, who prescribe the device to patients. With the latest clearance, it can now ramp up direct-to-patient marketing. It’s bringing on Irvine-based marketing agency Gigasavvy to help with the launch.
“We’ve been in the home market for quite a while. That has always been our focus … if you want to take that pill bottle from patients, you have to have something that they can take home,” Heaney said.
The family-owned company was founded in Huntington Beach in 1981. Its flagship H-Wave device can be used in a clinical setting but is most effective when used at home several times per week or day. Sessions typically last 30 to 60 minutes each.
“We provide individualized training and support to help you [use the device at home],” Heaney said. The company, which has over 150 employees, puts about 75 in the field to work with patients. Education and support are available to all customers, including for the over-the-counter home device.
The company said H-Wave’s technology stands apart from other electrotherapy modalities. “Most electrical stimulation devices are about masking pain while the device is on. We want to get to the root cause of the pain,” Heaney said.
H-Wave is covered by some insurance plans, but the bulk of sales are through a national federal supply contract to military veterans hospitals. Heaney said self-pay is currently less than 10% of its business, but “that is where we are looking to actively grow.”
Professional sports franchises have also been customers.
He said the increase in out-of-pocket expenses means U.S. patients have to decide “what you have to do with that money if you want the best care.”
The home H-Wave costs about $3,300 with self-pay.
All services, including manufacturing, repairs and research and development, are done in-house. Its Huntington Beach headquarters totals 27,000 square feet.
Growing Avid
Tustin-based biologics manufacturer Avid Bioservices added Acumen Pharmaceuticals Inc. as a client, providing process development and clinical manufacturing services for ACU193, the Livermore-based drug company’s candidate to treat Alzheimer’s disease.
“This agreement with Acumen is the latest of what we expect will be several near-term client wins [as we continue] to expand and diversify our customer base,” Chief Executive Roger Lias said. Lias, who joined the company in September, replaced former Chief Executive Steve King when King resigned in December.
Avid, formerly Peregrine Pharmaceuticals, restructured after investors issued a public statement in July. It changed its board and management—Chief Financial Officer Paul Lytle also announced his resignation last month—and sold its immunotherapy drug candidate to Oncologie Inc. in Boston.
The company previously funded clinical development of its drug with cash-generating subsidiary Avid. It’s now a pure-play contract development and manufacturing services provider.
Shares of the company trade at nearly $5 for about a $200 million market cap.
Bladder Help
Aliso Viejo-based Soft Health Technologies launched Finess Softpatch, which is designed to help women struggling with bladder leaks caused by exercise, sneezing or coughing. The company said about one in three women, approximately 20 million, have the problem. Issues include wet underwear and odor.
Soft Health said that unlike most products, Finess Softpatch is designed to prevent leaks rather than capturing them. Its product is placed over the urethral opening, and a hydrogel adhesive seals it in its place to prevent urine from leaking until it’s removed. It can be used during “rigorous activities like running or CrossFit,” according to the company.
Breast Implants
Irvine-based Mentor Worldwide LLC, a breast aesthetics company and part of the Johnson & Johnson medical devices companies, announced it received a high safety indication. Results of the 10-year U.S. multicenter study involving 955 patients—designed to study the safety and effectiveness of contour profile gel MemoryShape Implants—were published in the Plastic and Reconstructive Surgery publication.
