A Medical Device Daily

Acclarent (Menlo Park, California), a developer of surgical devices for ear, nose and throat applications, has filed for an $86.25 million initial public offering.

The company said it plans to use proceeds from the offering for sales, marketing and training, research and development, clinical and regulatory initiatives and general corporate purposes.

The company is focused on commercializing its balloon sinuplasty devices which doctors use to treat patients with chronic sinusitis.

The FDA cleared Acclarent's first model of its balloon sinuplasty device in 2005 and the company launched the product later that year, then began international sales in 2007.

For the three months ended March 31, Acclarent reported a loss of $8.6 million, widened from a loss of $5.6 million in the year-ago period. Revenue for the period was $10.2 million, more than double the year-earlier period's $3.9 million.

The IPO is being underwritten by JPMorgan, Piper Jaffray, Leerink Swann and RBC Capital Markets.

The company has raised about $63 million in funding from firms that include New Enterprise Associates, Versant Ventures and Delphi Ventures, and Meritech Capital Partners.

Entellus Medical (Maple Grove, Minnesota), developer of a new treatment for chronic sinusitis, said it has raised $15 million in Series C funding to commercialize its medical device technology and achieve high-level penetration in its target population.

"We're excited to give ENT [ear, nose and throat] doctors and their patients an alternative that reduces pain, bleeding and recovery time compared to traditional sinus surgery – and one that also eliminates the need for general anesthesia," said Tom Ressemann, president/CEO of Entellus.

Ressemann said the latest round of funding will be used to expand third-party payer reimbursements to include office settings – a first for sinus surgery. In addition, the funding will allow the company to launch the technology nationwide this fall, with extensive outreach, training and support for ENT surgeons to adopt the treatment.

The round was led by new investor Montagu Newhall Associates and supported by existing investors Split Rock Partners and SV Life Sciences, which financed Entellus' Series A and B rounds.

"It certainly is an exciting time for Entellus Medical with the recent FDA clearance oftheir FinESS Sinus treatment," said Kevin Campbell, partner at Montagu Newhall Associates.

"With this new round of financing, we expect the company to be self-sustaining with the opportunity to deliver innovative and exciting technology to the ENT community," Ressemann said.

The company's treatment is designed to enlarge the maxillary sinus ostium and ethmoid infundibulum. Its FinESS sinus treatment is delivered into the sinus cavity via access underneath the lip instead of through the nasal passage required by other procedures. As a result, the company said it is less painful, requires little or no recovery time, and can be done with local instead of general anesthesia, as compared to traditional sinus surgeries.

Up to 60% of chronic sinusitis sufferers can benefit from this less-invasive treatment, it noted.

Entellus was founded in April 2006 by Tom Ressemann and Peter Keith, and ENT surgeon Theodore Truitt, MD.

In other financing news, Bulow BioTech Prosthetics (Nashville, Tennessee) a provider of customized one-on-one care to amputee patients throughout the country, said it has secured an undisclosed amount of new financing from Nashville-based Frist Capital.

The company said the new capital will be used for growth initiatives and general corporate purposes. Bulow currently operates prosthetic patient care centers in Nashville, Cookeville and Clarksville, Tennessee, that specialize in providing one-on-one patient care by employing the latest in prosthetic technology.