TherOx, an Irvine, Calif.-based medical device company, seeks $25 million for the final push to bring its treatment to increase the quality of life for heart attack patients. The company’s optimized “super-saturated oxygen” (SSO2) offers a solution to reduce infarct size by increasing oxygen to heart tissue damaged during percutaneous coronary intervention and stenting. Following an FDA advisory panel’s advice to gather more data, TherOx announced very promising results from a pilot study, AMIHOT II, at TCT 2013. They showed a 9.6 percent infarct size at 30 days in high-risk patients treated with its next-generation system for Supersaturated Oxygen (SSO2) Therapy, which surpassed the company’s goal of 15 percent. The goal is to save heart muscle tissue in heart attack patients, thus improving quality of life after a heart attack.
According to a press release: “In a previous prospective, multi-center, randomized IDE trial, AMIHOT II, patients treated with the first-generation SSO2 system had a 20 percent infarct size, and control group patients treated with PCI alone had a 26.5 percent median infarct size.” In this second study, the company zeroed in on patients with big anterior infarcts after acute myocardial infarction who had undergone PCI within six hours. This laser focus has offered the company much clearer and impressive results–that of 9.6 percent.
The wow factor of the innovation beyond these results? The company claims it can safely send this SSO2, which puts a concentration of oxygen five- to seven-times the normal level into the patient’s plasma, directly to the impacted tissue. “Rather than having it act like club soda we can control it. We’ve treated over 550 patients,” CEO Kevin Larkin said. “I don’t worry one bit about bubbling. We are so far below what I refer to as our ‘bubbling threshold.'”
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Here’s how:
Immediately following the interventional procedure, proprietary technology from TherOx mixes a pre-specified concentration of “SuperOxygenated” saline solution with the patient’s blood to produce SuperOxygenated blood. The SuperOxygenated blood is then delivered through a catheter to the oxygen deficient tissue. Company research has confirmed in clinical studies that SuperSaturated Oxygen Therapy has the potential to reverse ischemia and may resuscitate tissue that may otherwise die.
SSO2 Therapy circulates the patient’s own blood via the existing arterial access site used for the stenting procedure. Thus, no new access site is required.
“The more we can drive down infarcts in everybody—quality of life goes up overall,” Larkin said. “It’s important to remember that significant medical breakthroughs that really affect the lives of people. . .very often have a slow tortuous course.”
The company is 15 years old and Larkin has been with the company for more than a decade.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“That’s a long time. Full PMA products that are new and novel don’t generally come easily or quickly.”
TherOx is still venture-backed, and many of the investors have been with the medical device company since the beginning or halfway point. Investors include Kleiner Perkins Caufield and Byers; New Science Ventures; Integral Capital Partners; Aperture Venture Partners; DAG Ventures; and Cross Creek Capital.
Larkin said venture capital is as risk-adverse as it’s ever been. The company is on the hunt for $25 million, which would carry the therapy through the PMA process and the company through the next two-and-a-half years. The company’s looking to “non-destructive” sources of funding, potentially in corporate venture capital or non-U.S. entities, Larkin said.
The second generation of the system has a CE Mark, so an investor could market the device in Europe, if interested, Larkin said.
Recent tests show “SSO2 can keep more large anterior infarct patients off the heart failure path or relegate them to a lower heart failure classification.”
Larkin said it could help “interventional cardiologists who have to look patients in the eye and say, ‘You know, Bill, you’ve got class III heart failure. . . . Your heart’s 50 percent bigger than it’s supposed to be. We can’t fix that, can’t undo that. . . . You’re kinda stuck, I can’t fix you.'”
If the company finds the funding it seeks and all goes according to plan, the therapy could be commercialized in the U.S. by mid-2016, Larkin said.
For Larkin’s advice to PMA-route medtech startups seeking venture capital, click here. (It’s among my favorite CEO advice. It’s no-nonsense.)
Follow MedCity News on Facebook and Twitter for more updates.
