Holaira - 2014 Fierce 15

CEO: Dr. Dennis Wahr
Based: Plymouth, MN
Founded: 2008
Website: www.holaira.com

The scoop: Drug options for chronic obstructive pulmonary disease (COPD) are only modestly effective. Holaira is betting that its lung denervation device can improve COPD treatment, either as a replacement for drugs or in addition to them.

COPD is characterized by persistent airflow limitation caused by progressive narrowing of the airways. This leads to shortness of breath, wheezing, chest tightness and a productive cough. More than 190 million people worldwide, including 15 million U.S. adults, have COPD, according to the company. There are no curative drugs, they are only for symptom management.

What makes Holaira Fierce: Holaira's technology is a catheter-based system used in a procedure called Targeted Lung Denervation (TLD). Like anticholinergic COPD drugs, such as Spiriva and Atrovent, TLD targets the parasympathetic innervation of the lungs. The one-time bronchoscopic procedure ablates the nerves at the top of the lungs, thereby relaxing the airways beyond it.

"By interrupting those nerves, the airways can dilate," said Holaira President and CEO Dr. Dennis Wahr in an interview with FierceMedicalDevices. "This mechanism is how the anticholinergic drugs like Spiriva work. Spiriva works by blocking the parasympathetic system. It releases acetylcholine and when that hits the lungs it causes them to constrict."

He continued, "Pharmaceuticals block the acetylcholine. What we do is working on the same pathway, which we do by ablating the nerves upstream." He added that in its clinical trials, Holaira is using the same clinical endpoints as drugs, primarily FEV1 (forced expiratory volume), the 6-minute walk test and improvement in quality of life.

The company has done two feasibility studies in a total of 37 patients. It hasn't released detailed data yet but expects to have data published in a peer-reviewed publication in the coming weeks.

Although he couldn't offer any feasibility data details, Wahr said the company was able to raise a $42 million round on the strength of preclinical data earlier this year.

The Series D round closed in April; it was led by Vertex Venture Holdings with participation from Windham Venture Partners, Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners, and Versant Ventures.

What to look for: Wahr said this financing will be sufficient to complete a Phase II study that has already started enrolling. He added that the company will pursue a clinical path that is more akin to drug testing including preclinical, Phase I, Phase II and Phase III, rather than the more typical medical device path from feasibility directly to pivotal testing.

Wahr noted that he thinks medical device development should be more similar to the track for drugs, citing $100 million to $140 million and 8 to 10 years as the norm for development of a novel device aiming for a PMA.

Holaira expects to have full Phase II data, including 12 months of follow-up, by the end of 2016. The Phase III trial would take an additional two years after that, pushing a potential FDA approval out into 2019. -- Stacy Lawrence (email | Twitter)

For more:
Investments in Minnesota life science companies take big Q2 jump
Venture capitalist spending bonanza lifts med tech investment in Q2
Holaira brings in $42M Series D to test COPD lung denervation treatment tool

Holaira - 2014 Fierce 15
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