Category: news

The “Innovation Gap” is an increasingly important issue in the medical device industry. New, life-impacting technologies are not being developed in part because of the lengthening time required to bring new products to market (by some estimates over 5.5 years for 510(k) devices and 8-10 years for PMA products). Additionally, the number of deals and total dollars invested in seed and early stage med tech companies has declined by 45% from 2008 and 2016. A consequence of this decline is an increasing consolidation and concentration of technology in the hands of a few very large medical device firms. Once the Abbott/St. Jude merger is complete, Abbott and Medtronic will control 20% of all PMA devices in the US and this will likely impact the speed and frequency of medical product innovation. A further consequence of the increasing challenges in medical device development is that the needs of both the venture community and of these very large firms is understandably directed almost exclusively at very large markets, leaving many smaller yet important medical areas underserved. These factors are driving a need for new business models and new methods of bringing medical technology to market. At Minnetronix, we are creating effective solutions to address the innovation challenge:

1. We provide infrastructure, technology, regulatory expertise, and seamless engineering to commercialization services for medical device companies. With decades of device development experience and a best-in-class quality system, we’ve helped hundreds of companies launch new products while contributing to client enterprise value. Our ability to reduce the operating burden for small firms that may have burn rates of $750k – $1M / month, has helped clients save millions of dollars off the cost of bringing their products to market. For large firms, Minnetronix has proven to be a fast and cost effective strategic partner that can quickly enhance and manufacture products or product portfolios while helping to manage operating costs.
2. Our portfolio of proprietary and licensable technologies is a cost-effective way for our customers to enhance their product value and increase speed to market. A few examples of these technologies include Minnetronix’ Cognita wireless communications and cloud infrastructure, our wireless energy technologies, and our integrated blood pump power and control systems.
3. At Minnetronix, we are developing unique and meaningful technologies and therapies for small, underserved markets. We are able to effectively address these smaller markets by leveraging our established infrastructure and deep device experience to pursue technology development without the need for a “standing army”. The Innovation Gap in medical technology is real and is calling for new business models. Minnetronix is responding to the call by providing services and technology solutions that benefit our medical manufacturing partners and serve the medical marketplace at large.

Richard Nazarian is the President and Chief Executive Officer of Minnetronix, Inc.

New York, NY: Altaris Capital Partners, LLC announces acquisition of Senior Helpers.
Senior Helpers, headquartered in Timonium, MD, is a leading franchisor of private pay, professional home care for elderly individuals, with over 280 active territories across 39 states. The Company differentiates itself with its proprietary, specialized programs that have been developed in collaboration with leading medical experts, and was the first provider in the industry to offer specialized care services for individuals with Alzheimer’s, dementia and Parkinson’s disease. www.seniorhelpers.com.
About Altaris Capital Partners, LLC
Altaris Capital Partners, LLC is an investment firm focused exclusively on the healthcare industry. Managing $1.5 billion of equity capital, Altaris invests in businesses that meet clearly defined healthcare needs and leverages its extensive industry knowledge and relationships to accelerate growth and value appreciation. Altaris is based in New York, NY. For more information visit www.altariscap.com.

Dayton, OH Oct 5, 2016 – For over 25 years, global healthcare agencies and disaster relief organizations have trusted CSafe to protect temperature-sensitive lifesaving supplies being transported to the most extreme locations. CSafe is offering to provide disaster-relief organizations responding to areas affected by Hurricane Matthew its industry leading thermal shipping solutions to help protect medicines and medical equipment being transported into these areas.
CSafe Global is an expert in cold chain solutions and produces actively controlled mobile refrigeration units for life sciences, healthcare, military and international disaster relief agencies. They are once again working with aid organizations and medical facilities in the affected areas by offering the use of their mobile battery powered, temperature-controlled containers for transporting and storing blood, vaccines and other temperature-sensitive healthcare supplies.
Products available to disaster-responding agencies include passive insulated shipping boxes, active mobile containers, (such as the company’s AX56L mobile refrigerator/freezer which can be powered by AC or battery) and the RKN refrigerated pallet sized air cargo container. These packaging solutions thrive on thermal integrity and proficient operation which results in a secure shipment and delivery to those in need, boosting the resiliency of disaster-stricken areas.
For more information, relief agencies and medical facilities working in the areas affected by the hurricane can contact CSafe directly at +1 937-245-6387 or via disasterrelief@csafeglobal.com.

Dayton, OH Sept 14, 2016 – CSafe Global, having recently acquired Kalibox, will be introducing the Kalibox passive pallet shipper to the US market at the 14th IQPC Temperature Management Logistics Conference in Boston, MA.
The passive Kalibox branded pallet shipper features an innovative time and cost saving design which includes a patented quick assembly system and easy opening and loading. The front-loading shipper offers up to five days of thermal protection and is available in a range of sizes from 200 liters to 1500 liters.
Adding Kalibox to its product fold is just the latest in a whole series of exciting developments at CSafe Global. “Over the past year we have established new business operations in Korea, Japan, France and Puerto Rico, opened nine new service centers, introduced our “CATS” container tracking system, launched several new products and passed the landmark production total of 1000 RKNs”, reports Brian Kohr, CEO at CSafe. “These impressive achievements are the result of CSafe’s continual investment in staff, facilities and technology and look forward to maintaining our strong growth trajectory.”
Nadine Siqueland, Vice President of Global Sales at CSafe, underlines the importance of giving customers the widest choice: “Biopharmaceuticals are steadily becoming more complex and environmentally sensitive as technology evolves and at the same time, shippers are facing growing regulatory pressures. Couple these factors to the industry’s relentless globalization and you start to see why today’s pharma shipper needs access to a wider range of cold chain solutions than ever before. At CSafe we have an unwavering commitment to providing the best, most comprehensive and most efficient cold chain protection for all our customers’ needs.”

Paris, France Sept 1, 2016 – CSafe Global is proud to confirm the completion of the acquisition of Kalibox. With two manufacturing locations in France, Kalibox is a leader in providing cold chain packaging solutions throughout Europe. The acquisition continues CSafe’s global expansion plans adding over 5000 square meters of manufacturing in two European locations to its current six North American locations that total over 20,000 square meters. These are CSafe’s first owned facilities in the EU.
Kalibox was founded in 2001 and manufactures temperature-controlled packaging including insulated shippers, patented design insulated pallet shippers and refrigerants. Based in France, Kalibox specializes in providing solutions for the safe transportation of life saving medicines. Thanks to its accredited testing laboratory, Kalibox has developed a strong expertise in the development and qualification of passive solutions.
Brian Kohr, President and CEO of CSafe stated, “The acquisition of Kalibox is an important milestone for CSafe as we work hard to be able to continue to support our global customers with the right solutions for their cold chain shipments. We are solely focused on helping our life science customers have the best solution for their needs.”
Antoine Soulas, CEO of Kalibox and Christophe Langerock, COO of Kalibox jointly stated “The merger with CSafe is a strategic move for Kalibox and its customers. It will allow us to accelerate our development, accompany our customers globally, and create value for them in significantly extending our product offering in Europe. Kalibox shares with CSafe the same dedication to high quality products and services to protect our customers’ valuable payload. We are proud to join the CSafe team, building a strong global leader.”
Brian Kohr concluded: “CSafe currently has the industry’s broadest line of cold chain solutions. This investment to expand our product offering to include an alternate but needed design of passive packaging along with a line of passive pallet shippers and gel bricks allows CSafe to continue to help our customers create the most efficient, effective, reliable and secure temperature controlled supply chain. We will continue to provide cold chain solutions and adapt them to meet our customer’s needs and not sell ‘one-size fits everyone’ products. The vision of the company over the last 25 years has never altered – to be the most trusted name in cold chain solutions.
About Kalibox
Kalibox is a specialist in the design and manufacture of temperature-controlled packaging for pharmaceutical and other healthcare applications. Kalibox offers a full range of innovative solutions to cope with uncertain thermal conditions during transit including insulated pallet shippers, pre-qualified cold chain containers and insulated courier bags. It also manufactures thermal stabilizer packs using its patented TRB (Thermal Regulated Buffer) technology. The company has comprehensive, accredited, in-house testing and metrology facilities and is able to design and develop customized cold chain solutions for the most demanding customer requirements. Kalibox is based near Paris in France with ready access to all the main European markets.
For further information, visit http://www.kalibox.com/
Click here to view video.

Saint Paul, MN Aug 29, 2016 – Minnetronix, Inc., a leading medical technology and innovation company, announced that Anthony Millar has joined the company as Vice President of Operations. Millar has more than 15 years of healthcare industry experience in manufacturing, new product development, supply chain, quality assurance and compliance.
Millar will play an integral role on Minnetronix’ leadership team, developing strategies to grow and expand capabilities for the company’s manufacturing operations. He will also oversee Minnetronix’ highly experienced production teams in the manufacturing of technologies and devices for the company and its customers.
“Anthony has a wealth of industry experience and proven leadership in device manufacturing,” said Jeremy Maniak, Minnetronix Chief Operating Officer. “We are pleased to welcome him to Minnetronix and know he will be a great asset to the company as we continue to grow and expand our operations.”
Millar joins Minnetronix from Greatbatch Medical, where he led manufacturing operations for multiple sites as Executive Director of Operations. Prior to Greatbatch, Millar served as the Director of Operations for MedImmune, a division of AztraZeneca. His experience also includes multiple manufacturing and engineering management positions at Boston Scientific and production and finance positions at Guidant. Before his career in the healthcare industry, Millar served as an officer in the United States Marine Corps.
“I am excited to join Minnetronix at such a dynamic time in the company’s history,” said Millar. “Minnetronix has a very promising future and I look forward to contributing to the company’s success.”
Millar is a Six Sigma Black Belt with significant experience in the application of Lean and Six Sigma methodologies. He earned his Bachelor of Arts in Political Science from the University of Illinois. He was also awarded a Master of Science in Business Administration from Boston University and is currently pursuing a Master of Engineering Management from Penn State.
About Minnetronix
Minnetronix is a medical technology and innovation company with deep expertise in electronic and electromechanical devices. Founded in 1996, the company creates new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies. Minnetronix is FDA Registered and ISO 13485 Certified.

Dayton, OH Aug 22, 2016 – CSafe Global continues to strategically expand the team of Sales Directors supporting superior cold chain solutions to global Life Science companies.
CSafe Global announced the appointment of Abigail French as the company’s newest Director of Strategic Life Science Sales. Mrs. French, who is based in North Carolina, will be responsible for contributing to CSafe’s overall business growth while she consults with the regions biopharma, medical device, and partner companies. With extensive experience in biotech, pharmaceutical, medical device, and temperature control markets, Abigail will be an integral participant in the company’s global market penetration strategy.
Before joining CSafe, Abigail held top performing sales positions within LABRepCo, Covidien/Medtronic, and Aventis. “I am extremely impressed with the CSafe Global portfolio of cold chain solutions and its unrivalled value proposition”, remarked Abigail. “It’s an exciting time. CSafe is uniquely positioned as the only global manufacturer with a full suite of both active and passive temperature management solutions. I’ve been in this industry a long time and to join a company that’s completely committed seeking the best solutions without limiting their options to one particular technology is exciting!”
CSafe Global has become the world leader in temperature-controlled containers for sensitive pharma and medical products and this new appointment is part of the company’s ambitious expansion plans. With its principal biopharma market continuing to grow continuing to grow significantly, the company is investing heavily in expanding its international footprint and in pioneering innovative, market-leading solutions.
Commenting on the new appointment, Nadine Siqueland, Vice President of Global Sales said: “Abigail is an excellent addition to our growing and experienced team and will contribute substantial sales management experience and expertise. As a President’s Club top-performer with a consultative approach, Abigail will bring great value to our fast-growing, world-class team.” Nadine went on to share: “Much of our expediential growth is driven by Life Science companies and partners that increasingly choose to work with CSafe as a single-source partner, recognizing our unique ability to problem solve their most complex cold chain challenges with both active and passive cold chain solutions. They understand that we are focused on serving their patients who are receiving critical, life-saving biopharmaceutical, biosimilar and medical device treatments that require the most robust solutions. There is no other global manufacturer with the breadth and depth of cold chain offerings that CSafe brings, which is why on-boarding talented professionals like Abigail, who will leverage her deep industry knowledge to further expand our market growth lead, is so important.”

Dayton, OH Aug 9, 2016 – CSafe Global announces a significant strategic growth milestone with the manufacture of the 1000th RKN active container.
This accomplishment is a testament to the dedication of our manufacturing, customer service, technical support and sales team as we continue meet the increasing demand from biopharmaceutical companies for the CSafe RKN. Biologics and vaccines, the most temperature sensitive products to make and transport, dominate the drug treatments developed and commercially available to patients today. These high value biologics require the most robust temperature protection available during transport, resulting in the majority of biopharmaceutical companies increasingly relying upon the CSafe RKN to safeguard their new treatment medicines. We pause to thank the growing number of life science companies and partners that have trusted the superior quality of the CSafe RKN since the production of our first container almost nine years ago.
Life Science companies recognize the CSafe RKN for its efficiency, reliability and continuity of performance. This is due in part to CSafe Global’s industry unique presentative maintenance program which insures every RKN in the CSafe fleet to have the performance equivalent to those that are newly manufactured. CSafe supports customers with online ordering, instant temperature data download, flexible leasing programs including one-way leases, and a large global service network. The CSafe RKN utilizes heating and compressor-driven cooling technology combined with our proprietary ThermoCor^® insulation technology. This combination of active and passive technology in one solution, provides the widest range of temperature protection for the longest duration in ambient conditions ranging from -30°C to +49°C.
The RKN is part of CSafe’s comprehensive portfolio of temperature-sensitive transportation solutions that includes active and passive pallet shippers, passive and active small parcel packaging and hand-held courier solutions. The transportation of every biopharmaceutical shipment is a journey that concludes with a patient’s health and safety in mind. There is no margin for error. Drugs must be shipped safely and securely and kept within these tight temperature parameters. The transportation of these biologics often includes long, multi-day journeys which can involve the traversing of hemispheres, continents, and countries. Transfers between multiple modes of transport, huge temperature and climatic variations combined with global training and language barriers all add to the temperature stability risk. CSafe solutions provide the superior cold chain packaging which overcomes these challenges delivering the performance that our customers need while driving cost efficiencies over most existing packaging systems.
To support the growing RKN fleet and the addition of new business entities in France, the Netherlands, Japan, Korea and Puerto Rico, CSafe will add eight new service centre sites to our global network in 2016.
To view the video, visit https://youtu.be/WbFYlu7qsg8

Austin, TX Jul 20, 2016 – HealthTronics, Inc., a mobile medical technology company has acquired mobile laser technology company, Mobile Medical Marketing, LLC (Mobile Medical), based in Albuquerque, New Mexico.
“With this acquisition, we’re delivering on our strategy to become the first choice for our customers when seeking laser treatments and other mobile medical technology applications,” explained Russell Newman, president of HealthTronics.
Mobile Medical provides various laser therapies for ENT, neurology and ob-gyn procedures to hospital systems, surgery centers and physician offices in Albuquerque. The acquisition expands HealthTronics’ fleet of mobilized medical technology and strengthens its reach into other areas of the U.S., including New Mexico.
Earlier this year, HealthTronics acquired United Therapies, a provider of mobile lithotripsy and laser technology to healthcare providers in the Midwest, Northeast and Southwest regions of the United States.
“Rising healthcare costs have made mobile medical technology an attractive option for reducing costs among hospitals and surgical centers. By utilizing mobile equipment, providers can have access to new technology and treatments when they otherwise could not afford the costs associated with purchasing and maintaining the equipment,” said Newman.
HealthTronics’ technology is “mobile” because the company delivers the medical device to the health care facility where the physician conducts each procedure. In addition to servicing and updating the equipment, each delivery includes a dedicated, highly trained HealthTronics’ technologist to assist with the operation of the equipment.
Click here to read the Austin Business Journal story.

Dayton, OH Jul 18, 2016 – Cold chain specialist CSafe Global recently hosted an event to celebrate the opening of their San Juan service center and new company CSafe Puerto Rico LLC.
The open house was at the company’s new service center adjacent to the island’s Luis Muñoz Marín International Airport (SJU). Over fifty customers and partners attended the celebration and took advantage of the opportunity to tour the new service center and showroom where CSafe’s complete line of active, passive packaging and passive hand-held couriers were on display.
CSafe has a well-earned record for quality and reliability and recognizes service centers are the key to providing customers with the solutions that give consistently high operational performance and a long service life. Brian Kohr, President and CEO stated, “We pride ourselves on having the best maintenance program in the industry. Our rigorous inspection, monitoring and preventative maintenance program insures that no matter the length of time a CSafe RKN container has been in the fleet, its performance will be the same as the new units that are being produced daily in our US manufacturing facility. ”
The opening of the new CSafe facility was prefaced by the arrival of over one hundred CSafe active shipping containers. In what is probably a first for the industry, CSafe Global procured several full 747F charter aircrafts to move CSafe RKN ULDs into Puerto Rico. The containers are being utilized to support the country’s growing manufacturing industry and as part of a customer specific solution.
In addition to the CSafe RKN, CSafe’s passive and small active solutions will be available for use within and for shipments leaving Puerto Rico. CSafe will also be able to provide conditioned and ready to use passive and active solutions from its own facility, further evidence of their continuing commitment to provide innovative customer solutions.