See original story here ABK Biomedical Inc., a company dedicated to the research, development and commercialization of innovative embolic therapies, has announced the appointment of Michael J. Mangano as president and CEO. Mangano will be responsible for leading global business activities, including the rapid development, regulatory approval and commercialization of ABK’s unique medical device technologies. Mangano most recently served as president and CEO of ReShape Medical, a US venture-backed company focused on obesity where he increased organizational value and played a lead role in orchestrating the sale of the company to EnteroMedics in October 2017. Prior to ReShape, Mangano was president of the Americas for Sirtex Medical, a leading publicly traded Australian biomedical company, where he grew the business nearly five-fold from $30 million to more than $140 million while building a team of 17 to more than 130 employees in six years. His leadership resulted in a dramatic increase in the company’s valuation, leading to the recently announced acquisition in progress of Sirtex Medical by CDH Investments for $1.4 billion USD. Prior to Sirtex, Mangano spent 15 years with Boston Scientific in numerous senior management roles, including overseas assignments in Japan and Australia. Mangano was recently appointed to the board of directors of Ellex Medical Lasers Limited (ASX:ELX), a global leader in medical devices for the diagnosis and treatment of eye diseases. ABK Biomedical chair Dr. Aaron Berez commented, “Mike is an accomplished leader with a history of global success in building dynamic teams, leading organizational change, creating and shaping strategies and executing programs – all directly increasing shareholder value. His vast experience in sales and marketing management, product development, strategic planning, international business, M&A, project management and business model development will be invaluable as he takes the reins at ABK and leads the company into the next phase of our evolution.” Mangano will continue to serve on the ABK board of directors. “I am excited to join the team at ABK, which has outstanding experience in the medical device industry. The talent at ABK, coupled with an innovative technology platform and pipeline, provide a strong foundation and solid prospects for our future growth and success,” said Mangano. “I especially look forward to working with the interventional radiology and oncology communities to develop and market novel technologies that will help patients and physicians, and want to thank the founders and the board of ABK for their support.” Dr. Bob Abraham, co-founder and former CEO, is a practicing interventional radiologist and will remain with the company as chief medical officer. He will continue to play a key role in product development and the clinical evolution of ABK’s key technology platforms. About ABK Biomedical Inc. ABK Biomedical is organized to research, develop and commercialize breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. Specifically, ABK holds intellectual property in the focus area of inorganic polymer microspheres, targeted at the growing field of embolotherapy within the interventional radiology/interventional oncology medical disciplines. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique, breakthrough embolotherapy products. For more information, please contact: Elizabeth Romero Fleishman Hillard 919.457.0749 firstname.lastname@example.org Gary Donofrio ABK Biomedical Inc. 617.513.9575 email@example.com Halifax, Nova Scotia, July 30, 2018]]>
See original story here ABK Biomedical has raised more than $9 million in an over-subscribed round of equity funding that closed last August. The larger equity base has allowed the company to borrow $3 million from the Atlantic Innovation Fund. The Halifax-based medical device maker revealed that it closed the Series A funding round – one of the largest in Atlantic Canada last year – during discussions about its latest borrowing from the AIF, a fund operated by the Atlantic Canada Opportunities Agency. ABK is working to improve a process used to kill some forms of tumour: tiny beads cling to tumours, depriving them of blood flow and thereby shrinking or killing them. The company hopes that its first product – which is now awaiting regulatory approval in the U.S. – will be one of the first beads on the market that can be seen by x-ray, and this will help doctors assess how well the treatment is working. As well as helping to finance regulatory applications, the company said the new funds will help it to manufacture its products in Nova Scotia once it receives regulatory clearance. “The AIF funding announced yesterday will be supporting some of the most advanced medical device manufacturing capabilities in this region, and will help us to succeed as an Atlantic Canadian medical device company that will manufacture locally and sell novel life-saving products globally,” said CEO Bob Abraham in an email Friday. It had been known that ABK was raising money, though the size of the round was surprising. Abraham said the company was originally after $7.6 million in funding but it attracted more commitments than expected, with most of the funding coming from the U.S. and Asia. Innovacorp, which had invested in the company previously, contributed $1.1 million to the round. ecognition of the value of our portfolio of imageable embolic products in development, the great team we had assembled and importantly, the recognition of the significant support ABK receives in Atlantic Canada through organizations such as ACOA,” said Abraham. ABK – which last raised funding in 2014 through the Halifax-based First Angel Network and Wilmington Investor Network of North Carolina – was one of several Nova Scotian startups to close funding rounds of $8 million or more last year. Halifax’s Manifold, Affinio, Metamaterial Technologies and Liverpool, NS-based Aqualitas all closed major rounds. (The Aqualitas round may be considered to be more project financing for its core cannabis business.) The next big news for ABK is likely to be regulatory clearance in the U.S. for its first product, the x-ray-visible beads. This product is currently being evaluated by the Food and Drug Administration in a 510k application, which establishes whether a device is safe and effective. ABK hopes to gain approval later this year, “after which we are planning a controlled launch into the U.S. market,” said Abraham. He added the company hopes for Health Canada approval in late 2019. Abraham also said the company is working on another series of beads, the Y-90 radioembolic product, which actually emits radiation. “We are quite excited about the potential of this product to be a game changer in our field,” said Abraham, adding that the regulatory requirements mean it will have a longer road to commercialization. ABK is also in the early stages of developing a degradable bead which will block blood supply to tumours then disappear from the body after a short period of time. Disclosure: ACOA and Innovacorp are clients of Entrevestor.]]>
See original article in LINK Magazine
Every year brilliant discoveries are made in Dalhousie University’s research labs but without commercialization support many of those discoveries may never lead to potential social or economic benefits. The Industry Liaison and Innovation (ILI) Office, which is the business development arm of the university, is working to get those discoveries out of the labs and into the real world.
“We work to unite talented researchers with local and international companies to help them grow their business and become more competitive,” says Stephen Hartlen, assistant Vice-President of industry relations at Dalhousie and Executive Director of Industry Liaison and Innovation.
One of those unions was made when the ILI office began to work with Diagnostic Radiology Professor, Dr. Daniel Boyd and Dr. Bob Abraham an Interventional Radiologist. The office saw commercial potential in their research ideas and encouraged them to launch the company known today as ABK BioMedical.
Another success story came from Agada Biosciences, who reached out to the ILI office to investigate the prospects of transplanting their company from Washington, DC to Nova Scotia. ILI was pivotal in demonstrating the tremendous support programs for Nova Scotia life sciences companies to help ensure their success, Agada moved to Nova Scotia in 2013. Agada now employs numerous Dalhousie graduates and has extensive partnerships within the Faculty of Medicine.
The commercialization of research discoveries in Nova Scotia is an important financial boost to the region’s economy. With Dalhousie poised as the largest research enterprise in Atlantic Canada and the ILI office facilitating meaningful industry collaborations, more companies like ABK are being launched. The economic and social benefits are far reaching and include the attraction of big industry, investment, start-up formation, job creation and further contributions to research and development in the region.
The office is also a valuable asset to the business community through the transfer of knowledge and technology from the university into the hands of industry. Companies not only benefit from the collaborative facilitation and guidance of the ILI office but can also access various funding initiatives as well.
“We’re proud to be part of the innovation ecosystem in Atlantic Canada and will continue to foster meaningful collaborations with industry,” says Hartlen.
See original article in LINK Magazine
Diagnostic Radiology Professor, Dr. Daniel Boyd had just moved from the Republic of Ireland when he walked into Dalhousie’s Industry Liaison and Innovation Office to discuss an innovative idea he had to develop an X-ray visible technology in the treatment of cancerous tumors. In an ironic twist of fate, Dr. Bob Abraham an Interventional Radiologist was looking for a partner to develop that same technology. The connection between the two was soon made and a third person, Dalhousie Scientist, Sharon Kehoe was brought into the fold to start the company known today as ABK BioMedical (A = Abraham, B = Boyd, K = Kehoe).
Excited about the potential to impact the cancer market they sought out funding opportunities to develop their new technology. In the fall of 2011 they entered The BioInnovation Challenge, an investment competition organized by BioNova, the Nova Scotia life sciences association with the potential to win $30,000 in seed funding and advisory services. They pitched a compelling product they called OccluRad, which involved tiny x-ray visible bio-compatible glass beads used to treat uterine fibroids, or benign tumors in a woman’s uterus.
Today doctors are treating this condition by introducing particles through a blood vessel, which targets the tumors and causes them to shrink. The problem with today’s technology is that the particles are invisible to X-ray, meaning doctors can’t personalize the treatment to optimize the patients’ healthcare. This problem provided the team at ABK BioMedical an opportunity to improve on that treatment process with x-ray visible beads that would increase the effectiveness of the patients’ procedure.
ABK Biomedical’s development of OccluRad particles in the treatment of fibroid tumors, was deemed the most attractive for investment by the panel of judges. Their compelling product pitch would win them The BioInnovation Challenge, which was in its inaugural year. Through the support of the competition they were able to incorporate their business and invest further into research and development. The experience would also open new doors for investment opportunities that would help them build a strong platform to bring their product to market. Today the company has three products in development and are planning to launch them in Europe and the U.S in 2016.
See original Entrevestor article
by Peter Moreira
Two Halifax medtech companies, ABK Biomedical and Densitas, will travel to San Francisco next month to take part in the Dose of the Valley – a mentoring and networking event for Canadian life sciences companies.
The Bay Area is renowned as the global hotbed for information technology startups, and for years Canadian IT companies have been attending 48 Hours in the Valley – an event that helps Canadian startups benefit from resources in the area.
Last year the Canadian Commission in San Francisco and C100 (a group that helps Canadian startups make connections in Silicon Valley) began Dose of the Valley for the biopharma, medical device and health IT sectors. ABK and Densitas have been selected for the event Feb. 9 and 10.
CTA Offers Wealth of Mentorship in Boston
“It’s kind of nice that we’ve been selected as one of the medtech companies from across Canada,” said ABK Chief Executive Bob Abraham. “It gives us a chance to meet with partners from across the United States. … My understanding is the event itself is attracting a large number of multinationals who want to see what Canadians are up to.”
His counterpart at Densitas, CEO Mohamed Abdolell, said Dose of the Valley would be a “power networking” event where there would be intense meetings not only with mentors but also investors, opinion leaders, industry partners and potential acquirers.
Most of the medical-technology companies in Atlantic Canada tend to seek mentorship in the life sciences community in Boston due to proximity. But Abdolell said Silicon Valley is a hotbed of health-related IT, especially in terms of data analytics. These are big parts of Densitas’ business so the 48 hours in California will be especially beneficial.
ABK is the developer of OccluSystem, which improves efficiency and safety when treating women for uterine fibroids, or benign tumours, in the uterus. The system uses tiny bio-compatible glass beads to help monitor the deterioration of the tumours following procedures that are designed to eradicate the growths.
The company is now preparing to make its 510(K) submission in the U.S. in the next few months. This is the filing that the Food and Drug Administration requires to establish that a medical device is safe. ABK is also preparing for ISO Certification, which is required to complete regulatory approvals in the European Union, Canada and the U.S. Abraham said the company expects to have a product on the market in 2017.
ABK last raised funding in 2014 through the First Angel Network and Wilmington Investor Network in North Carolina. The company hopes to raise venture capital investment this year.
Densitas last month received regulatory clearance in the European Union and Canada to sell its first product, DM-Density, which enhances breast screening by assessing breast density. Breast density is a key determinant in a patient’s risk of contracting breast cancer, so Densitas helps doctors understand a patient’s risk profile.
Scott Moffitt, the managing director of the Nova Scotia life sciences association BioNova, said the fact these two companies were selected for the event shows the quality of medtech companies being developed on the East Coast.
“It really gives some credibility to the type of companies we’re generating in this part of the world,” he said. “The selection process is a competitive one so it lends credence to our belief in what we’re doing here. It shows that the companies are complex and that they’re strong from the business perspective.”