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| Histogenics' NeoCart implant--Courtesy of Histogenics |
Implantable tissue repair player Histogenics has filed for an initial public offering to raise up to $65 million. The financing is to fund an ongoing Phase III trial for its NeoCart, an implant to repair knee cartilage damage. Meanwhile, Molecular diagnostics company AutoGenomics is hoping the third time's the charm with its IPO filing for up to $60 million.
Histogenics and AutoGenomics aren't alone. Two more med tech companies--neurostimulation startups NeuroSigma and EndoStim are slated to price soon.
The Phase III trial for Histogenics' NeoCart is slated to complete enrollment during the first half of 2016. The NeoCart implant is made using a patient's own cartilage harvested from a cartilage surface on the femur that doesn't bear weight. These cells are cultivated and embedded in a collagen scaffold and incubated. Once there are early signs of chondrocyte function, which characterizes healthy cartilage, the neocartilage is shipped to a surgical facility and implanted in the knee using the company's bioadhesive.
The trial is designed to demonstrate the superiority of NeoCart over microfracture. Microfacture is a surgical procedure for several cartilage defects; it consists of making surgical perforations in the bone plate at the location of the cartilage damage to allow bone marrow cells access to the injured area. But microfracture is only a short term solution since the resulting growth is a mix of tissue types that is not as durable over time as cartilage.
Sofinnova Ventures (27% pre-IPO stake), Split Rock Partners (18%), Altima Partners (6.9%) and Boston Millennia Partners (5.9%) are among Histogenics' investors. Through June 30, the startup had lost $122.5 million.
Existing investors have already committed to buying up to $15 million in the IPO. Synthetic biology company Intrexon holds a $10 million promissory note that converts at the IPO; it has also said it will buy up to $15 million of IPO shares.
As for AutoGenomics, it is filing again after two previous failed forays. The company markets 62 diagnostic tests and has another additional in development. Among these are personalized medicine test panels in pain management, cardiovascular health assessment, oncology and mental health. It had $19 million in sales for the 12 months ended June 30.
Neurostimulator company NeuroSigma postponed its anticipated $50 million IPO on Oct. 9 citing poor market conditions. That doesn't bode well for another neuromodulation startup, EndoStim, that's expected to price a $35 million IPO on or around Oct. 20. NeuroSigma has a device in development to treat drug-resistant epilepsy and depression.
EndoStim has a neurostimulator to treat gastroesophageal reflux disease (GERD) that's in pivotal U.S. testing. It plans to target the 5% of GERD patients that the company says still experience symptoms while on medication. The startup is expects to sell 3.2 million shares at $10 to $12 each to raise $35 million.
- here are the SEC filings for Histogenics and Autogenomics
- and the road shows and prospectuses for NeuroSigma and EndoStim