Three med tech companies recently disclosed their intentions to go public. These include breast implant maker Sientra, noninvasive neurostimulation player Nexstim and rheumatology diagnostics company Exagen.
Breast implant maker Sientra filed for an IPO to raise up to $86 million. It's close to profitability, but not quite there yet. This IPO could give it the boost it needs to get there.
Sientra markets 120 different breast implants using high-strength, cohesive silicone gel and proprietary exterior texturing it calls True Texture. The idea is to improve the softness and life-like feel of the implants in the body; the implant also seems to reduce the rate of complications a bit.
FDA approved Sientra's implants in 2012 based on what the company said is the largest prospective, long-term safety and effectiveness pivotal study of breast implants ever conducted in the U.S. of 1,788 patients.
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| Sientra breast implant--Courtesy of Sientra |
In the 5-year study, Sientra reported slightly lower rates of several complications than competitors Allergan and Mentor. However, those companies reported 6-year, rather than 5-year, data. For Sientra, the rate of rupture was 2.1%, capsular contracture was 9.8%, and re-operation was 24%.
Sientra had $21.9 million in net sales during the first half of 2014, with an operational loss of $2.6 million. That's up from $17.9 million in net sales in the first half of last year, with an operational loss of $9.2 million.
Since its 2005 inception, Sientra has raised $151 million in equity from investors including OrbiMed (33.8% pre-IPO stake), Clarus Ventures (29.8%) Abingworth (18.6%), Goldman Sachs (8.6%) and the Teachers Insurance and Annuity Association of America (6.9%).
At June 30, Sientra had $21.6 million in cash, so fundraising isn't a necessity but could rather be to provide an exit for VCs and a higher profile for the company. It has raised $25.2 million in debt.
In Europe, noninvasive brain stimulation company Nexstim has said it is pursuing an IPO on NASDAQ OMX First North Finland and NASDAQ OMX First North Sweden during the fourth quarter.
The financing will help support its ongoing two-year, pivotal U.S. trial of its Navigated Brain Therapy system as a post-acute stroke therapy that started in June. A version of the system is already CE-marked and FDA-approved for pre-surgical mapping of the motor and speech cortices in the brain.
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| Nexstim's Navigated Brain Therapy system for stroke patients--Courtesy of Nexstim |
In a Phase II trial of the NBT System, 29 post-acute stroke patients were randomized into two groups with 19 patients receiving NBT therapy and 10 receiving sham treatment. In the group receiving NBT treatment, 84% showed a clinically important improvement in motor function of the upper extremities by six months after treatment, compared to 50% in the sham group, which was a statistically significant difference.
Nexstim hopes to have an FDA approval for the NBT System by the end of 2016.
The company's major shareholders include HealthCap, the Finnish Innovation Fund Sitra, Capricorn Health-Tech Fund, Life Science Partners and Lundbeckfond Ventures.
Finally, Exagen Diagnostics has filed to raise up to $69 million to market its blood tests that detect lupus and rheumatoid arthritis. The company processed 11,100 of its lead product Avise SLE in the first six months of 2014, up from 9,300 in 2013. The product is targeted at the roughly 3,500 rheumatologist in the U.S.
The company has raised about $82 million in equity and debt from investors including Sun Mountain Capital, Tullis Health Investors, Joseph Advisory Services, Signal Peak Ventures and Capital Royalty.
- here are the SEC filings for Sientra and Exagen
- and the release for Nexstim