Cincinnati, Ohio – AshHill Biomedical Investments, a U.S.-based private investment firm specializing in biomedical opportunities, announced several of its ventures recently passed significant FDA approval hurdles – including Orphan Drug Designation for a medication developed by one company and a Special Protocol Assessment (SPA) agreement for another company’s pharmaceutical.

Among the companies AshHill has invested in:

  • Armetheon, a pharmaceutical company offering an anticoagulant medication for patients with heart disease
  • Heart Metabolics, a pharmaceutical company offering a drug for a hereditary heart disease
  • Sinusys, a medical device company developing a minimally invasive treatment for sinusitis

Recently, each of the companies made significant regulatory announcements. In April, Armetheon announced that it had reached a SPA agreement with the U.S. FDA for a Phase 3 trial of tecarfarin. At the same time, perhexiline, a medication from Heart Metabolics, received an Orphan Drug Designation from the FDA for treating hypertrophic cardiomyopathy, a hereditary heart disease. At Sinusys, the FDA cleared its Vent-Os sinus dilation system for use in January of this year.

“We’re so proud to be a part of bringing these medical innovations to the patients who need them,” said Dr. Peter Milner, Managing Director of AshHill Biomedical Investments. “We have a vision to use our investments and our expertise to meet unmet medical needs. Each of these great companies is doing that, and they’ve been successfully clearing the regulatory hurdles to bring these treatment options to doctors and their patients.”

As part of its investment strategy, AshHill takes active management roles, as well as scientific and support services, in the companies it invests in. Milner, who co-founded Optiva Biotechnology, CV Therapeutics and ARYx Therapeutics, lends his expertise in biotech start-ups and pharmaceutical research and development to the invested companies. On behalf of AshHill, Milner is working as the CEO of Heart Metabolics and serves on the board of Sinusys.

AshHill team members have also provided FDA application assistance and worked on the design for clinical trials. On the entrepreneurial side, David Buffenbarger, AshHill’s CFO, has provided financial reporting, auditing and funding expertise to the invested companies.

“AshHill Investments is designed to give people an opportunity to be make investments in pharmaceutical, medical device and related biotech industries. The stock market isn’t the only place to invest in medical innovation,” said Buffenberger, a CPA and financial adviser based in Cincinnati, Ohio.

Large, publicly traded pharmaceutical companies are rethinking the way they spend on Research & Development. Estimates put the typical cost of developing a new medication between $350 million and $5 billion for big pharmaceutical firms, according to an analysis by Forbes in 2013. Some are transitioning to other avenues, such as acquisition of treatments developed by smaller firms that are further down the regulatory and clinical trial pathway.

“As big pharmaceutical companies change the way they’re thinking about R&D, it opens the door for small companies that take a laser approach to specific medical conditions and their treatments. At AshHill, we’re seeking out those seed-stage companies to make investments and be a part of their groundbreaking work,” Buffenbarger said.

Regulatory agencies, like the FDA, are also changing the R&D environment with expedited processes for bringing specialized treatments to market – such as Orphan Drug Designation, approval for medications treating rare conditions with patient populations of fewer than 200,000 people; Breakthrough Therapy Designation, to expedite the review and approval of treatments for serious and life-threatening conditions; and Special Protocol Assessments, an acceptance process for efficacy data from a treatment’s Phase 3 clinical trial.

One example of the new trend in regulation: there were more Orphan Drug Designations in 2013 – 17 drugs – than in any other year since the passage of the Orphan Drug Act in 1983. In April, the FDA also announced a new program, the Expedited Access Premarket Approval Application program, to speed medical device approvals for patients who have no other treatment options – a parallel to a similar pharmaceutical approval program.

“Navigating the capital funding process and the regulatory process can be daunting for biotech entrepreneurs. They have great ideas and innovations. They’re doing important work, and our role is to assist them in that process – with funding, with expertise in medicine and biotech and with active management,” said Steven R. Smith, General Counsel for AshHill Biomedical Investments and a Cincinnati attorney. “The AshHill team is uniquely positioned to provide its investors and its invested companies with all three.”

About AshHill
AshHill is a private investment firm with a specialized focus on the biomedical sector and participating in its portfolio companies in active management roles, as well as scientific and support services. Its mission is to discover, analyze and invest in start-up, seed-stage and established companies that are working to develop medical innovations. The firm’s leadership, including physicians, researchers and entrepreneurs bring experience in the establishment, development, management and sale of pharmaceutical companies to optimize investments and help bring pharmaceuticals and medical devices through the regulatory process and into the marketplace. Visit for more information.