Government of Canada supports prototype development, regulatory approvals and research commercialization

August 7, 2018 – Halifax, NS – Atlantic Canada Opportunities Agency

Great innovation happening here in Atlantic Canada is growing our economy, creating well-paying jobs, and improving the lives of Canadians. That is why the Government of Canada is supporting Covina Biomedical Inc. as it advances a proprietary bone cement used in the repair of knee implants, the single biggest problem in orthopedics today.

Andy Fillmore, Parliamentary Secretary for the Minister of Democratic Institutions and Member of Parliament for Halifax, announced a $500,000 repayable investment in Covina Biomedical on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development, and Minister responsible for the Atlantic Canada Opportunities Agency (ACOA).

The assistance will help Covina Biomedical prove the effectiveness of its injectable bone cement for orthopedic patient care. Customer feedback and validation will prepare the company for clinical trials and develop a roadmap to obtain regulatory approval in Canada and the United States. Together, these initiatives will position Covina to scale-up, creating new economic benefits for Atlantic Canada.

Intellectual property for Covina’s injectable bone cement that prevents invasive surgery is the result of an earlier ACOA project with Dalhousie University. The product is being developed and commercialized in Nova Scotia, creating up to six new full-time, highly skilled positions and maintaining two others.

This contribution is being made through ACOA’s Business Development Program, which works with small and medium-sized companies to improve competitiveness in export markets.

The investment builds on the commitments made by the Government of Canada and the four Atlantic Provinces to drive economic growth in Atlantic Canada through the Atlantic Growth Strategy. The Strategy supports targeted investments in initiatives that build on the region’s competitive advantages, such as its strong export potential and skilled labour to expand business activities between the region and international markets.

 

Quotes

“Covina represents the benefits of collaboration between academia and industry. Commercializing research out of our universities and into the real world where it will help Canadians is one of the markers that will distinguish Canada as a world-leading economy now and for the long-term. This will help to create growing, innovative businesses with global reach, good jobs, and a thriving middle class.”

–       The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for ACOA 

“It’s very exciting to see the outcome of local research and development result in a product that can be commercialized and exported globally. Covina Biomedical has tremendous potential to assist patients suffering from osteoarthritis or failed knee implants, and to contribute to the local, flourishing life sciences community.”

–       Andy Fillmore, Parliamentary Secretary to the Minister of Democratic Institutions and Member of Parliament for Halifax 

“Our company was founded on the passion to improve patient outcomes amidst a growing healthcare crisis of rising costs and wait times, and to do it here, in Atlantic Canada. The continued support of ACOA is helping to make this exciting opportunity possible, by supporting first, the transition of this high-quality research from Dalhousie University, and now, the continued development of our novel technology and growth of our company in the region.”

–       Dr. Caitlin Pierlot, CEO, Covina Biomedical Inc.

“The support of ACOA through the AIF program which funded the initial research at Dalhousie was instrumental. As the largest research intensive University in Atlantic Canada, Dal is a knowledge-generating institution and the ideal environment to pursue discoveries. We are proud to have partnered the technology with Covina and look forward to assisting them as they grow as a company. This is a great example of a bold research discovery that will have far reaching patient impact.”

–     Stephen Hartlen, Executive Director of Industry Liaison and Innovation and Assistant Vice-President of Industry Relations, Dalhousie University

Quick facts

  • The orthopaedic market is forecasted to exceed $45 billion in the United States by 2021.
  • Knee replacements are the single biggest problem in orthopaedics today with the global market worth over $8.4 billion (USD).
  • Age and BMI are key risk factors in the onset and progression of musculoskeletal conditions of the hip and knee, resulting in significant risk of requiring one or more joint implants in a lifetime.

    – In 2016, more than 1.9 billion adults were overweight, and of these, 650 million were obese

    – By 2050, nearly 20 per cent of the global population will be over the age of 65

  • The number of knee joint implants is expected to rise to 185,000 procedures per year in the US by 2025.
  • Average total cost of care of a single knee joint implant procedure in the US was estimated at $100,000 in 2014.

Contacts

Alex Smith
Director of Communications & Outreach
Atlantic Canada Opportunities Agency
Phone: (902-426-9417 | 902-830-3939 (cell)
Email: alex.smith@canada.ca

Caitlin Pierlot
Chief Executive Officer
Covina Biomedical Inc.
Phone: (902) 442-4014 | 902-495-9008 (cell)
Email: cpierlot@covinabiomedical.com

Michèle Charlton
Communications Advisor, Research
Dalhousie University
Phone: 902-494-4148
Email: michele.charlton@dal.ca

Halifax-based DGI Clinical has launched a new app, SymptomGuide Dementia, that allows caregivers to track and manage symptoms of Alzheimer’s disease.

The app allows caregivers to learn about dementia, including Alzheimer’s disease, and provides management strategies for dealing with symptoms.

Caregivers can choose those symptoms most important to them and share progress with family and clinicians. The app is functional on iOS devices and available free on the app store.

“Over two decades of research and conversation with people living with dementia and their caregivers has formed the foundation of SymptomGuide Dementia,” Dr. Kenneth Rockwood, President and Chief Scientific Officer of the company said in a statement.

Rockwood, a geriatrician and Alzheimer’s disease researcher, said the app is designed to give caregivers comprehensive, current information about dementia, its symptoms, stages, treatments as well as an easy-to-use method of capturing an individual’s information and experience in a manner that’s meaningful for the caregiver.

“Our hope is that the information tracked with SymptomGuideTM Dementia will be used for discussion with family members and for shared decision-making with clinicians.”

The app was launched at the Alzheimer’s Association International Conference in Chicago, an event attended by over 5,600 clinicians, researchers and industry scientists, the statement said.

In Canada, the Alzheimer’s Society reports almost 600,000 Canadians are living with dementia. In the US, the Alzheimer’s Association indicates that 5.7 million Americans are currently living with Alzheimer’s disease, a number projected to reach nearly 14 million by 2050.

Over 16 million Americans currently provide care for people living with Alzheimer’s disease and other forms of dementia. Most are unpaid family members who suffer an emotional, financial, and physical toll as a result of caring for people living with Alzheimer’s disease. the statement said.

DGI has a suite of proprietary electronic Clinical Outcome Assessment (eCOA) tools for licensed use by sponsors in drug development. The company’s products focus mostly on digital tools for diseases of the central nervous system such as dementia, Parkinson disease, and schizophrenia but also include applications for other chronic, complex diseases such as hemophilia

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
elizabeth.romero@fleishman.com

Gary Donofrio
ABK Biomedical Inc.
617.513.9575
g.donofrio@abkbiomedical.com

Halifax, Nova Scotia, July 30, 2018

See original article here

New Antibiotic Formulation Designed to Treat Parasitic and Anaerobic Bacterial Infections; Appili Will Use Study Data as Basis for NDA Filing

HALIFAX, Nova Scotia, July 30, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today positive top-line results of a pivotal relative bioavailability study evaluating pharmacokinetics, safety, and palatability of ATI-1501 in healthy, normal adults. Data from this study will be used to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for ATI-1501 in early 2019. ATI-1501 is a proprietary, taste-masked oral suspension formulation of the antibiotic metronidazole, which is broadly prescribed to treat parasitic and anaerobic bacterial infections that heavily burden the elderly.

The clinical study results announced today showed that a single 500 mg dose of ATI-1501 achieved equivalent systemic drug levels to a 500 mg metronidazole tablet under fasted and fed conditions. ATI-1501 was well tolerated and safety observations for ATI-1501 were consistent with the known safety profile of metronidazole.

“Appili Therapeutics set out to address an unmet medical need – namely to provide an alternative antibiotic solution for patients with difficulty swallowing.  Our clinical data demonstrate that ATI-1501 has an acceptable safety profile while being more palatable than metronidazole tablets for a vulnerable patient population,” said Jamie Doran, MSc, DABT, ERT,Vice President of Drug Development for Appili. “As we move towards a submission to the FDA for market approval, we anticipate that ATI-1501 will soon be available to healthcare providers and caregivers as an excellent alternate treatment option for those with serious infections requiring treatment with metronidazole.”

In many countries, including the US and Canada, oral metronidazole is only available in solid forms. Patients with difficulty swallowing the oral tablet require pharmacists, the patients themselves or caregivers to crush the drug and add it to food prior to patients ingesting it. This process increases risk for dosing error and amplifies the pronounced bitter taste of metronidazole that can negatively impact patients’ ability to comply with their full treatment regimen. The bitter taste of metronidazole is so pronounced that it is listed as an adverse event on the drug label.  ATI-1501 has been designed to offer patients with difficulty swallowing the drug a more palatable, easy-to-take liquid suspension alternative.

About the Bioavailability Study

The primary objective of the randomized, open-label, single-dose, two-sequence, cross-over clinical study was to assess the relative bioavailability of ATI-1501 compared to the reference product Flagyl® (solid metronidazole tablets) under fasted and fed conditions. Clinicians performed the study under an Investigational New Drug application (IND) and a Clinical Trial Application (CTA) approved, respectively, by the US Food and Drug Administration and Health Canada in 2017. A total of 44 healthy adults aged 18 to 63 years completed the study.

A planned subset of participants was also asked to evaluate the taste properties and relative preference for ATI-1501 compared to metronidazole crushed in applesauce, which is the current standard of care for elderly and pediatric patients with difficulty swallowing. Palatability measures were assessed using the 9-point hedonic scale, the most widely recognized and used scale to measure taste preference and selection in the food industry. A total of 25 participants participated in this palatability and preference component, ranging from 18 to 63 years of age. ATI-1501 exhibited meaningful and statistically significant improvements across all palatability measures (taste, bitterness, smell, texture) compared to crushed tablets with a corresponding reduction in bitterness scores and a strong preference for ATI-1501 over the current standard of care.

Based on these findings, Appili expects to submit complete study results for publication in a peer-reviewed medical journal.

“We are currently pursuing commercial manufacturing activities to support an NDA filing in the first quarter of 2019,” said Appili CEO Kevin Sullivan, MBA. “In addition, we are actively engaged in commercialization and licensing activities to maximize patient access to ATI-1501 in US and global markets.”

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

Media Relations Contact:
Christy Curran, Sam Brown Inc.
T: 615-414-8668
E: christycurran@sambrown.com

Investor Relations Contact:
Kimberly Stephens, CFO, Appili Therapeutics
T: 902-442-4655
E: Info@AppiliTherapeutics.com

Will enable mammography quality improvement and population level stratified breast screening.

HALIFAX, NS., Canada, July 24, 2018 /PRNewswire/ ‑ Densitas, Inc., a breast imaging analytics innovator based in Halifax, Nova Scotia, announces a recently formalized partnership with the Leeds Teaching Hospitals NHS Trust in the UK. The partnership seeks to introduce innovative personalized breast screening technologies, including our DENSITAS|density™ and DENSITAS|quality™ products, into routine clinical workflow. The goal is to ultimately enable population level stratified breast screening and mammography quality improvement and stimulate research in the area of breast health.

“Our partnership  with Leeds Teaching Hospitals, NHS Trust is the first of its kind in the UK and represents an alignment of vision that is intended to improve appropriateness of care in breast cancer screening through innovation in technology and service delivery,” says Mohamed Abdolell, CEO of Densitas. “We are excited to collaborate with Dr. Nisha Sharma, Director of Breast Screening, and her team at Leeds Teaching Hospital’s NHS Trust breast screening program to introduce our machine learning powered breast imaging analytics platform into a clinical care setting.”

Breast tissue density is a confirmed independent risk factor for breast cancer in women. The current standard of care in the UK National Health Service is subjective, visual assessment of breast tissue density by the radiologist, if it is performed at all. The Densitas|density™ software provides an automated mechanism for quantifying and recording breast density, and making it readily available to the radiologist, along with the digital mammograms. This will allow the Leeds team to assess breast density for every woman who has a screening mammogram performed. Beyond speeding and simplifying the process of quantifying breast density, Densitas|density™ standardizes the density measurement and enables stratification of screen eligible women to ensure those who need more aggressive follow-up receive it, while those who do not need aggressive follow-up do not receive unnecessary imaging. Densitas software is unique in that it assesses breast density using the routinely archived processed DICOM images that radiologists normally review, and therefore supports prospective and retrospective breast density measurement for clinical care and for research.

Dr Sharma said: “This is a really exciting development for us because it has the potential to make a real difference to the quality of our screening program and ultimately to the health outcomes of women in Leeds. I’m very pleased that the Leeds Breast Screening unit and research team have the opportunity to collaborate with Densitas. This is the foundation for future developments that will improve breast care, so it’s excellent news for women.”

About Densitas:

Densitas, Inc. develops advanced breast imaging analytics technologies powered by machine learning. Our goal is to deliver actionable insights at the point-of-care that improve the quality of breast health management. Our products address the key challenges facing women’s imaging today, including mammography quality, workflow efficiencies, compliance with national guidelines, and delivery of appropriate care at sustainable costs. Learn more at www.densitas.health

For further information: Alex Morris, 647-470-4363

See original release here 

FOR IMMEDIATE RELEASE

BlueLight Analytics, a Halifax-based health tech company, is significantly expanding its senior management team.

BlueLight has had a year full of milestone achievements so far. The company has expanded its checkMARC service to over 35 countries around the world, secured new partnerships with leading dental manufacturers, and have collected more than 1 million data points through over 70,000 checkMARC evaluations. With no sign of momentum slowing, the company has made three strategic additions to the senior management team, welcoming Theresa Lee (VP Business Development), Derek Leblanc (VP Technology), and Matt Cooper (VP Product and Marketing).

JP Furey, BlueLight’s CEO, is making it a priority to bring additional experience to the team, continuing its rapid growth this year. These changes will also ensure that many of their younger employees, most recent graduates, have the mentorship they need to grow.  “We have a lot of exciting things on the horizon. We’re focused on building an all-star team that’s going to help us get to the next level. Derek, Theresa and Matt are experts in their fields and have brought new experience, insight and energy to the company. The BlueLight team is ready for the next stage of growth!”

Theresa Lee, VP, Business Development 
Theresa Lee joined BlueLight as VP, Business Development in April. She has a true passion for sales and has spent the past 16 years of her career in a variety of B2B roles with companies such as Johnson & Johnson, Siemens, Axis Dental, and most recently with Halifax-based STI Technologies Ltd, which was bought by QuintilesIMS in 2017. Her solutions sales and data experience coupled with her enthusiasm has made her a terrific fit to lead and support the business development team at BlueLight Analytics.
Derek Leblanc, VP, Technology
Derek Leblanc has returned to his full time role at BlueLight this past month as VP, Technology after working in Vancouver at Intel. With over 15 years of experience as a software engineer and researcher in machine learning, including 4 years as VP Technical Development at Afinin Labs in St. John’s, NL, he brings his passion for developing quality software and pushing the boundaries of computer science & industry to the BlueLight team. Derek has been leading the development of BlueLight’s new AI-powered next generation technology.
Matt Cooper, VP, Product and Marketing
Matt Cooper has joined as BlueLight’s new VP, Product and Marketing. Before joining BlueLight Analytics, Matt was the co-founder and Chief Product Officer at Swept Technologies, a mobile and web communication platform designed for the commercial cleaning industry. An active member and contributor to Halifax’s thriving startup ecosystem, Matt brings more than 20 years of experience in product development and marketing to the BlueLight team.

As Lee, Leblanc, and Cooper get settled into their new roles, the team is gearing up for a year of milestone achievements and are already planning  some more exciting updates to share in the coming months.

About BlueLight Analytics
BlueLight uses data to improve patient outcomes by changing the way dental filling materials and curing lights are developed, sold, and used. Their technologies collect data on curing lights and materials used in dental offices, which can be used by dental companies to inform marketing, R&D, and dentists to improve their clinical protocols. BlueLight’s solutions are used in over 35 countries around the world and have been used to conduct over 70,000 evaluations of curing lights at more than 16,000 clinics.

Media Inquiries?
Please contact Matt Cooper at 902.880.6288

Semi-finalists in BioNova’s BioInnovation Challenge (BIC) get to hone their pitching skills during one-on-one training with Linda Plano, an expert pitch training coach with over 10 years of experience mentoring entrepreneurs with start-ups in life sciences, cleantech, high tech, web-based applications and more.

Upon earning a PhD in Materials Science and Engineering from Stanford University and a BS in Physics from MIT, Plano held positions at various startup companies including research scientist and CEO, as well as management positions up to Vice President for New Business Development in more established companies. The combination of her high-level education and experience in business has allowed her to help entrepreneurs in many complex fields.

Plano has been coaching entrepreneurs on their pitches and value propositions since 2005. She founded Plano & Simple in 2010 to focus exclusively on coaching, training and mentoring entrepreneurs. This has led her to work with nearly 600 entrepreneurs, who have gone on to raise well over $250M. Plano has worked with a diverse number of clients, from first time entrepreneurs, to serial entrepreneurs and intrapreneurs. Although she is based in Boston, she has delivered her services to clients all over the world.

BIC Semi-finalists will get one-on-one training with Plano to perfect their pitches before presenting them to the BIC judges during BioPort 2018, Atlantic Canada’s premier health and life sciences event. BioPort is happening on November 7th and 8th at the Halifax Convention Centre. With a top prize of $25,000 in funding and $30,000 in in-kind services, BIC is set to highlight the potential of the many growing Health and Life Sciences start-ups in Atlantic Canada. BIC applications are open until August 10th.

You can learn more about Linda Plano and her work by visiting her website or following her on Twitter @lindaplano.

Working to Improve Hemophilia A Testing: Precision BioLogic presents new data at the 64th Annual SSC meeting

For Immediate Release

HALIFAX, July 19, 2018—Precision BioLogic today unveiled data from a study using a new kit for a Modified Nijmegen-Bethesda Assay (MNBA) at the International Society on Thrombosis and Haemostasis’ Scientific and Standardization Committee (SSC) meeting in Dublin. Recognizing the need to standardize and improve Factor VIII (FVIII) inhibitor testing for people with hemophilia A, the company developed the new MNBA kit and the recent study in collaboration with Roche and Genentech, a member of the Roche Group.

Data presented builds on findings released at the Thrombosis & Hemostasis Societies of North America (THSNA) 2018 Summit in San Diego, California and the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland. The latest data demonstrate that a bovine-based chromogenic MNBA is suitable for FVIII inhibitor measurement in plasma samples containing HEMLIBRA® (emicizumab-kxwh), a bispecific antibody that is approved by the U.S. Food and Drug Administration (FDA) and European Commission for the prophylactic treatment of hemophilia A with factor VIII inhibitors.

“We’re seeing promising advancements in the treatment of bleeding disorders,” says Paul Empey, President & CEO of Precision BioLogic. “We are hopeful that combining accurate diagnosis and monitoring with potential advancements could improve the quality of life for people with bleeding disorders. Precision BioLogic is proud to be at the forefront of this promising research.”

A poster of the latest study, Emicizumab Impact on Factor VIII Inhibitor Determination in Plasma Samples from Persons with Hemophilia A (PwHA) Using a New Kit for Modified Nijmegen-Bethesda Assay (MNBA), as well as previous studies, can be downloaded from the publications page of the Precision BioLogic website.

Precision BioLogic’s newly developed MNBA kit was used in the study. To eliminate FVIII depleted plasma as a potential source of variant and standardize inhibitor titer measurement, the kit was developed with the following components:

  • Imidazole-buffered pooled normal plasma
  • Imidazole-buffered bovine serum albumin
  • Positive FVIII inhibitor control
  • FVIII inhibitor-free human plasma

All kit components are frozen, like Precision BioLogic’s line of cryocheck™ diagnostic products, which closely resemble frozen patient samples.

Precision BioLogic plans to commercialize the kit and will seek clearance from regulatory authorities around the globe beginning in late 2018. The company is actively pursuing other opportunities to innovate in the field of hemostasis and diagnostics.

About Hemophilia A and Inhibitors

Hemophilia A is an inherited bleeding disorder caused by insufficient clotting factor VIII (FVIII) in the blood. People with hemophilia A experience prolonged bleeding, which can lead to permanent joint damage and life-threatening hemorrhages. The standard treatment for people with hemophilia A without inhibitors is intravenous (IV) FVIII replacement therapy with recombinant FVIII (rFVIII) or plasma-derived FVIII (pdFVIII) concentrates. Prophylaxis, the regular infusion of clotting factor concentrates, is used to prevent bleeds thereby minimizing joint damage.

Unfortunately, up to 30% of people with hemophilia A develop inhibitors, an immune response to treatment with clotting factor concentrates. Inhibitors make it more difficult to manage and treat hemophilia. In fact, according to the World Federation of Hemophilia, apart from access to care and treatment, inhibitors are the most serious challenge in hemophilia care today.1 While routine blood tests may suggest the presence of anti-factor FVIII antibodies, specialized testing is important to confirm not only the presence of inhibitors but also the quantitation to effectively adjust treatment. Current methods for inhibitor testing vary from lab to lab and there is not an FDA-cleared gold standard for reference.

About Precision BioLogic

Precision BioLogic is a privately-held company that develops, manufactures and markets specialized products used by medical professionals and researchers around the globe to diagnose coagulation disorders. Precision BioLogic also has several active initiatives with pharmaceutical partners who seek to ensure that the diagnostic implications for their novel therapeutic agents have been well characterized. For more information, visit www.precisionbiologic.com.

HEMLIBRA® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

– 30 –

For more information, contact:

Elaine Benoit, Marketing & Communications Manager

Precision BioLogic

ebenoit@precisionbiologic.com

902.430.7795

See original release here

HALIFAXJuly 18, 2018 /CNW/ – Adaptiiv, an innovative medical technology company announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market 3D Bolus Software, an advanced software solution that enables the creation of customized personal medical devices using 3D printing, used primarily in the treatment of cancer.

Adaptiiv’s software provides practitioners with a turn-key solution that enables 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy), High Dose Rate (HDR) surface brachytherapy and other potential ancillary devices. Adaptiiv software fully integrates with existing treatment planning systems and compliments the existing radiation treatment workflows.

Each module of Adaptiiv’s software is designed to solve challenges faced by today’s therapists, dosimetrists, and oncologists such as air gaps in bolus, sparing healthy tissues in electron treatments and the fabrication of complex brachy devices. The company’s software is already used in CanadaAustraliaIsraelIreland and England.

“This 510(k) clearance uniquely positions Adaptiiv to fuel the growth of personalized medicine through elegantly simple, intuitive technology,” notes Adaptiiv CEO, Peter Hickey. “Our technology platform is the first of its kind and allows users to easily design patient-specific devices that can be 3D printed and used during radiation treatment.”

Coupled with the recent announcement of its global distribution agreement with CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, Adaptiiv continues to make significant strides in the battle against cancer and transforming novel and experimental ideas into real world applications.

About Adaptiiv
Adaptiiv Medical Technologies Inc. (formerly 3D Bolus Inc.) is the definitive 3D technology platform for radiation oncology. Headquartered in Halifax, Nova Scotia, Canada Adaptiiv is shaping the future of patient-specific healthcare through innovation and collaboration with leading Cancer centres throughout the world..  Adaptiiv is ISO 13485 certified and has received a CE Mark.  Our technology is based on the work of Dr. James Robar, Chief of Medical Physics at the Nova Scotia Health Authority, in partnership with Dalhousie University in Halifax, Canada.

See original release here

Today, BioVectra Inc., a global Contract Development and Manufacturing Organization (CDMO) with microbial fermentation and synthesis capabilities with high containment, and TUBE Biopharmaceuticals GmbH, an Austrian biotech company active in the research field of cytotoxic payloads, announced that they have signed an exclusive license agreement for microbial fermentation technology to manufacture tubulysins.

After conducting further development, optimization and upscaling of the strain initially developed by TUBE Biopharmaceuticals, BioVectra intends to provide the marketplace with research- and cGMP-grade tubulysins and downstream derivatives.

Tubulysins belong to a cytotoxic tetrapeptidic natural product class that result in disruption of microtubule networks and inhibition of tubulin polymerization of cancer cells, and are suitable for use in conjugation approaches such as Antibody Drug Conjugates (ADCs), specifically targeting drug-resistant cancers.

Financial details of this unlimited agreement were not disclosed.

For more information, please contact Jordan MacGregor, at jmacgregor@biovectra.com.

About BioVectra

BioVectra is a CDMO that serves global pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in:

  • cGMP Microbial Fermentation
  • Complex Chemistry – High Potency APIs
  • Biologics
  • Formulation Development

For more information about BioVectra, please visit www.biovectra.com.

About TUBE Biopharmaceuticals

TUBE Pharmaceuticals GmbH (www.tubepharma.de) was founded in January 2011 in Austria having its labs in Vienna. TUBE Pharmaceuticals develops and commercializes drug candidates derived from natural products with high potency for novel therapeutic applications in the field of oncology. Together with advanced targeting approaches safer and more efficacious therapies especially preventing tumor resistance are to be expected for patients. In-licensing opportunities in the field of natural products derived oncology drugs closer to the clinics complement the internally developed assets of the Company and help to transform the Company into an oncology development company with an attractive pipeline to create further value.

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