Personalized drug metabolic diagnostic test company AltheaDx, cardiovascular imaging player Infraredx and brain-cooling device maker BeneChill have filed for IPOs in preparation for offerings that could come next year. They filed to raise up to $69 million, $55 million, and $14.7 million, respectively.
AltheaDx launched its IDgenetix test, which examines genes involved in the metabolism and pharmacological activity of a number of drugs, in the U.S. in October 2013. It has been used to test more than 13,500 patient samples tested through Sept. 30, 2014; of these, more than 7,500 were in the most recent quarter.
IDgenetix offers physicians information on metabolic enzymes and drug targets for individual patients. AltheaDx offers 13 tests in cardiovascular disease, neuropsychiatric disorders and pain; it is developing tests in neurology and rheumatology.
AltheaDx investors include Telegraph Hill Partners (43.9% pre-IPO stake) and Alma Life Sciences (24.5%). The startup has lost only $19.2 million since its 2008 inception. It had $13.6 million in revenue during the first nine months of 2014, with an operating loss of $5.3 million for that period.
Existing Infraredx investors may have a tough time getting a valuation that works for them, since they have already poured a huge amount of money into the company--$201 million since its inception in 1998. About $153 million of that was in equity, with the remainder in debt.
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| The optical catheter of the TVC System--Courtesy of Infraredx |
Infraredx is raising the money to market and conduct clinical trials on its dual-modality NIRS-IVUS True Vessel Characterization Imaging System (TVC System), an optical catheter that uses near-infrared spectroscopy to identify lipid core coronary plaques (LCPs), has been FDA-cleared since 2012. LCPs are associated with stent procedure complications and are suspected to be the plaques that cause the most heart attacks.
The company is in the process of conducting four prospective, outcomes-based studies that it hopes will show that liquid rich plaques (LRPs), of which LCPs are a subset, are vulnerable plaques, which are involved in heart attacks.
Infraredx had $3.7 million in sales during the first nine months of 2014, with an operating loss of $21 million during that period. Medical device giants Boston Scientific ($BSX), St. Jude Medical ($STJ) and the soon-to-be-acquired Volcano ($VOLC) are Infraredx competitors.
Investors in the company include Nipro, Eastwood Capital, Intrepid Maritime and Seahawk Investment Trust. The TVC System is partnered with medical device supplier Nipro in Japan and it is awaiting a reimbursement decision there in the first half of 2015.
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| The RhinoChill System--Courtesy of BeneChill |
As for BeneChill, it hopes to use the IPO to finance FDA approval, further clinical testing and European marketing of its RhinoChill System, which is designed to cool the brain to prevent trauma more effectively than existing methods.
The company expects to file with the FDA to treat malignant hypothermia in early 2015, based only on data with pigs. It said the agency is not requiring a human clinical study in this indication, since it's such a rare and unpredictable clinical event.
BeneChill investors include HealthCap (21.9%), MedVenture Associates (17.2%), NGN BioMed (16.4%), Physio-Control (8.4%) and Rütli Foundation Solon Medical (8.2%).
- here are the AltheaDx, Infraredx and BeneChill SEC filings
Special Report: FierceMedicalDevices' 2014 Fierce 15 - Infraredx