Medical device startup Laser Associated Sciences hopes to commercialize its patient monitoring device while staying lean on capital.
Co-founder and Chief Executive Sean White said the company, which will enroll patients in a multicenter, 100-patient phase one clinical trial this month, plans to go all the way to securing Food and Drug Administration approval with a $1 million investment from venture capital firm Auctus Global Capital Group in Newport Beach.
Irvine-based Laser Associated develops a noninvasive, laser-based device that measures blood flow in the legs, providing information such as peripheral blood circulation and arterial blockage.
“We saw a big gap in vascular medicine when it comes to peripheral artery disease,” White said. Peripheral vascular disease is a form of atherosclerosis that results in fatty deposits and calcium buildup in the walls of the arteries, causing narrowing of the blood vessels that restricts normal blood flow. Risk factors include obesity, unhealthy diet, smoking and diabetes.
White said there’s no treatment for the disease except angioplasty surgery. The gold standard procedure, in which a catheter is inserted through an artery and guided to the narrowed artery, calls for the balloon attached to the end of the catheter to briefly inflate, allowing its pressure to press the fat and calcium against the artery wall to improve blood flow.
“The doctors have no way of knowing if a surgery was successful during the surgery because there [are no devices] that measure the flow of the blood during surgery,” White said.
The device is designed as a guiding tool, tracking blood flow to the foot to identify blockage and whether blood flow has been restored. It’s clipped onto the patient’s toe during surgery.
Dr. Mahmood Razavi, an interventional radiologist affiliated with St. Joseph Hospital in Orange who’s assisting with patient trials, said the technology allows “real time [metrics] to optimize treatment.”
Razavi said there is currently no internal standard on how much is enough to re-establish blood flow except based on experience and angiogram. An angiogram is an X-ray that takes pictures of blood flow in an artery using a special dye and camera. The test, though, can’t be performed during the procedure.
Shiv Grewal, co-founder and a managing director at Auctus, said the device will alter peripheral artery disease procedures. That market exceeds $21 billion a year, according to a collaborative report by the American Association for Vascular Surgery.
White said the goal is to design a device that can be used in hospitals, plus at-home monitoring devices (see related Special Report story, page 16).
White has no plans to raise additional captial.
New Foot Forward
Freedom Innovations in Irvine added Maverick Comfort AT to its fiberglass foot line. The all-terrain model features aerospace-grade waterproof fiberglass material and regular and sandal-toe options.
The product, based on the Maverick Xtreme, which launched in January and is said to be the world’s lightest fiberglass foot, is designed for those who enjoy extreme activities and have active lifestyles.
Freedom Innovations has over 30 products in its portfolio, including carbon fiber and fiberglass feet, microprocessor ankles, microprocessor knees and hydraulic ankles. Its microprocessor ankle, Kinnex, which is manufactured in Irvine, will soon launch in Europe. Its products are equipped with Wi-Fi to support clinical reporting.
The company has 158 employees—including in its European headquarters in the Netherlands—51 based in its global headquarters in Irvine. It makes all of its prosthetics in the U.S. and has manufacturing sites in Irvine and Gunnason, Utah.
STEM
Amgen Foundation, the philanthropic arm of biopharmaceutical company Amgen Inc. in Thousand Oaks, invested an additional $10.5 million, for a total of $25 million, toward Amgen Biotech Experience, its three-week STEM education program, which helps expand biotechnology curriculum in middle schools and high schools.
Part of the funding will go to schools in Orange County, which include 13 campuses in Aliso Viejo, Anaheim, Fullerton, Irvine, Orange and Santa Ana.
Bits & Pieces
Mission Viejo-based Auxilio Inc. will assume the name CynergisTek, effective Friday. The healthcare document services provider acquired cybersecurity solutions arm, Austin, Texas-based CynergisTek, early this year for $34.4 million. The rebranding reflects a company strategy shift. … The Irvine-based Susan G. Komen Orange County will partner with the Los Angeles Chargers to raise awareness and funds for breast cancer. The creation of team Chargers for the Cure will be led by wide receiver and return specialist Travis Benjamin. The 26th Race for the Cure will take place on Sept. 24 at Fashion Island in Newport Beach.
