News

January 25, 2010 - NuOrtho Surgical selects Contract Manufacturing Partner

Fall River, MA, January 25, 2010 - NuOrtho Surgical, Inc., an innovative provider of leading edge surgical instruments today announced it has signed an agreement with Eagle Medical Inc. to provide Contract Manufacturing services. Under the agreement, Eagle Medical will be the manufacturer of NuOrtho's next generation, minimally invasive arthroscopic products.

"We are proud to announce this strategic relationship as we prepare to launch our first product, Ceruleau™ for people with knee pain. We conducted a lengthy search to find the right partner that could meet our high manufacturing expectations. Eagle Medical has a proven track record of working with leading medical device firms that positions them well to scale up around the globe with us", comments NuOrtho Surgical CEO Jeffrey Morrill.

NuOrtho Surgical is focused on surgical instruments to enable Tissue Preservation™ in the Orthopedic arena to improve patient outcomes. The technology leverages a low level Radio Frequency energy to restore mobility in patients by preserving healthy tissue in both soft and hard tissue procedures. NuOrtho has three primary product platforms for preserving healthy Tissue to sustain long-term mobility in our busy lives, particularly for Baby boomers. These platforms include Soft Tissue Treatment, Agent Delivery and Bone Fusion. The Bone Fusion technology is a game changer and can fuse bone together, and ultimately has the potential to replace screws and plates that are used in many procedures today.

Eagle Medical, located on the California Central Coast mid-way between San Francisco and Los Angeles, was designed to exceed today's regulatory requirements. Has a modern 10,000 square foot facility has over 1600 square feet of cleanroom and support area designed to provide a high quality environment for assembly and packaging of medical devices.

Eagle Medical's areas of expertise include manufacturing and packaging specialties, process and sterility validation studies, environmental controls, and bringing new products to market. We are well positioned for companies like NuOrtho Surgical and getting their innovative new products ready for FDA clearance and manufacturing “scale up” states Doyle Timmons Eagle Medical President.

January, 2010 - NuOrtho Surgical Names Ian McRury Ph.D. to leadership team as Chief Scientific Officer

FALL RIVER, MA (January 2010) - NuOrtho Surgical, Inc., a medical device firm focused on surgical instruments and procedures to enable Tissue Preservation™ in the orthopedic arena, is pleased to announce the addition of Ian McRury Ph.D. to the senior leadership of the company as Chief Scientific Officer. Dr. McRury brings a wealth of radio frequency knowledge and experience in bringing innovative products to market.

Dr. McRury has been working in the medical devices industry for the past 17 years with industry leaders including Davol, Johnson & Johnson and C.R. Bard. At DePuy Mitek, a division of Johnson & Johnson, he focused on rapid product development and transformational technologies such as the Platform Leader for Tissue Management. He has significant experience developing and launching RF products. During his tenure at Mitek, RF sales increased from $20MM to $75MM.

Dr. McRury holds a B.S. degree from Boston University and a master’s and doctor’s degree from the University of Virginia.

“The addition of Dr. McRury to our company signals another significant step toward building our team to advance the science of Tissue Preservation™ for the orthopedics market,” said NuOrtho Surgical CEO Jeff Morrill. “Dr. McRury brings tremendous experience and expertise to the commercial, clinical, technical and regulatory sides of our business. The reception and enthusiasm we have received from the medical and healthcare communities have helped us attract top talent like this to NuOrtho. These are exciting days as we prepare for our initial launch in the coming months.”

NuOrtho has three primary product platforms for preserving healthy tissue. These platforms include Soft Tissue Treatment, Agent Delivery and Bone Fusion. The Bone Fusion technology is revolutionary as it can fuse bone together, and ultimately has the potential to replace screws and plates that are used in many procedures today such as a simple ACL knee procedure. The company has nine issued patents. There are several additional patents pending in the Tissue Preservation™ arena.

January 17, 2010 - What’s Nu? Standard Times

NuOrtho Surgical, Inc., a medical device manufacturer start-up here has patented a surgical probe designed to preserve joint cartilage during orthopedic repair procedures and combat degenerative osteoarthritis of the knees, a problem that plagues millions as they age.

The company is planning to launch this innovative new technology early this year, pending FDA approval.

"This is a very exciting approach. If you can help someone with mid-range osteoarthritis improve their mobility and at the same time preserve the remaining healthy articular cartilage, that is a huge win-win," said Dr. Jeremy Stern, a well-known orthopedic surgeon who practices in the SouthCoast and is a member of NuOrtho's Advisory Panel.

NuOrtho was founded in September, 2008 by Jeffrey W Morrill, CEO, a marketing executive who worked in the medical device arena at Johnson & Johnson for eight years; Roy E. Morgan, a mechanical engineer with expertise in radiofrequency energy who worked at Stryker, Artemis Medical and Abbott Labs, and now serves as chief development officer; and Dr. Wayne K. Augé II, the chief clinical officer and a board-certified orthopedic surgeon. Morgan oversees research and development from California and Dr. Augé is located in New Mexico.

Morgan and Augé began creating a patent portfolio in 2003, and the company now holds nine patents for the tissue preservation technology and eight trademarks.

They put together their first million dollars in start-up financing in March, 2009 and a second million had been secured by November. The company continues to look for strategic partners to help the firm grow.

Osteoarthritis is a widespread problem in the United States, afflicting more than 20 million people — especially baby boomers — a primary market targeted by NuOrtho. According to www.MedicineNet.com, the degenerative condition affects more males before the age of 45. After age 55, it affects more women. Genetics can play a role, and sometimes it affects much younger people. Symptoms of osteoarthritis can include joint pain with activity, limited motion, joint inflammation, morning stiffness and pain at night.

According to the American Academy of Orthopaedic Surgeons' web site, www.aaos.org, the articular cartilage is located between the thigh bone and the shin bone, cushions the knee joint and helps muscles move the knee more efficiently. As the body ages, the cartilage becomes thinner and more vulnerable to fraying and lesions which can limit the gliding ability of the knee joint and severely limit mobility. Eventually, the cartilage breaks down completely, which results in the "bone-on-bone" situation which can require a total knee replacement.

"Once cartilage is gone, it's gone," said Morrill. "The goal of our new surgical probe is to allow the surgeon to preserve the healthy articular cartilage tissue while repairing and contouring the damaged area — using lower temperatures and lower levels of radiofrequency energy — all with the benefit of avoiding necrosis, the killing of healthy tissue."

The company has trademarked its probe, called Ceruleau, which means "blue water" in Latin and French. Like other probes already on the market, it is designed for one-time use while performing a surgical treatment for articular knee cartilage called a chondroplasty — a procedure where the damaged knee joint surface is carefully re-contoured to remove lesions and fraying and improve mobility.

The NuOrtho approach is designed to create a smooth cartilage surface without cutting, shaving or heating tissue to a high degree, all of which can create collateral tissue damage.

"This procedure can be a Catch-22," said Stern. "If you smooth the knee surface completely, you may sacrifice too much cartilage. If you leave it too rough, the knee may still get caught or stuck, which can limit mobility."

Morrill emphasized the careful attention paid to the design details of the probe, based on years of experience in the medical devices arena, combined with feedback from orthopedic surgeons.

"It has been reshaped to better fit the contour of the surgeon's hand as opposed to being stick-like," he commented. "The exterior surface has been texturized for better grip and improved surgical precision and control. And we added the power button to the probe handle itself instead of utilizing a floor pedal which requires additional cabling and more cords in the operating room."

Other benefits Morrill mentioned include enhanced patient recovery and reduced operating time, and lower costs to the surgical facility.

According to Morrill, choosing the SouthCoast for NuOrtho's corporate headquarters was a conscious decision. "We could have been on the river in Cambridge, but we felt the SouthCoast has a lot to offer and there is a strong labor pool available in the area. It's a way for us to ultimately contribute to the economic strength and stability of this region with some potential long-term job creation."

NuOrtho has been incubating at the Advanced Technology Manufacturing Center and currently employs 36 independent contractors or consultants on a full or part-time basis who have been working on developing the new technology and the prototype. When FDA approval comes, the company anticipates hiring about 100 new employees.

"The ATMC is an example of our regional efforts to promote continuing economic development in the SouthCoast area," said Robert A. Mellion, president and CEO of the Fall River Chamber of Commerce & Industry. "That's why NuOrtho's progress is so exciting. It is an innovative company with the potential for great success in the future — and the potential for new jobs in Fall River is always welcome news."

After Ceruleau is launched, the company is planning to adapt the design for use in other areas of the anatomy that typically present with wear and tear issues — shoulders, hips etc., as well as a new meniscal (knee) cartilage repair probe.

NuOrtho's core technology, trademarked Tissue Preservation, is the foundation of the product platform, with multiple future applications planned for soft tissue treatment, including a bone fusion product, which could replace the need for screws, pins or plates in orthopedic procedures.

"It's been an interesting ride," said Morrill. "For the first nine months, we were chasing potential investors, but now that has all changed, and they are chasing us."

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November 17, 2009 - NuOrtho Surgical secures $1 million in Series B Financing

Fall River, MA, November 17, 2009 — NuOrtho Surgical, Inc., a medical device firm focused on surgical instruments to enable Tissue Preservation™ in the orthopedic arena, announced today it has closed $1 million in Series B financing from private investors and individuals familiar with the orthopedic industry. The company plans to use the capital to file their FDA 510k application on their first product, scale up manufacturing capabilities and procure initial inventory for product launch in the first part of 2010.

“NuOrtho is the type of industry that Fall River is looking for. Projected job growth in the health care and medical manufacturing sector continues to be an area of opportunity for us. As a company that continues to be incubated and grow in the Advanced Technology and Manufacturing Center (ATMC), NuOrtho has a breadth of patented products that will take medical devices to the next level and create jobs for years to come. We look forward to accommodating each stage of growth in Fall River,” states Kenneth Fiola Jr., Executive Vice President of the Fall River Office of Economic Development.

NuOrtho CEO Jeffrey M. Morrill comments, “As the population ages, there is a growing need to sustain long-term mobility, particularly among baby boomers. The future is bright for innovative products that have a clear point of difference and benefits. Our technology leverages a low level Radio Frequency energy to restore mobility in patients by preserving healthy tissue in many procedures done today designed for both soft and hard tissue. While we await FDA approval, we are excited to build our team to commercialize our Tissue Preservation™ platform.”

Mr. Joseph A. Ciffolillo, a proven industry veteran, served in management positions with Boston Scientific Corporation (including Chief Operating Officer), Johnson & Johnson and Codman. Mr. Ciffolillo comments, “I have followed NuOrtho since inception. Their growth strategy and innovative product platforms have tremendous growth potential.”

NuOrtho has three primary product platforms for preserving healthy tissue. These platforms include Soft Tissue Treatment, Agent Delivery and Bone Fusion. The Bone Fusion technology is revolutionary as it can fuse bone together, and ultimately has the potential to replace screws and plates that are used in many procedures today (such as a simple ACL knee procedure). The company has added 4 new patents and now has 9 issued patents. There are several additional patents pending in the tissue Preservation™ arena. Their first product has early stage validation testing. The device will contour and smooth articular cartilage that has tears, lesions or is fraying, inhibiting knee mobility.

Company founders, Jeffrey W. Morrill, Dr. Wayne K. Auge II and Roy E. Morgan, have broad medical device experience and proven results of creating and launching new products and technologies (at Johnson & Johnson, as a surgeon and at Stryker respectively).

September 16, 2009 - NuOrtho Surgical Featured at Entrepreneur Forum

Fall River, MA September 16, 2009 - NuOrtho Surgical was the featured speaker at the Southern New England Entrepreneurs Forum (SNEEF) focusing on effective Business Planning at the UMASS Advance Technology and Manufacturing Center. The Forum attracted investors and entrepreneurs from the area to learn about creating and managing Business Plans from NuOrtho and the Panel of funding experts. The panel included moderator Bob Creeden who is Managing Partner of Partners Innovation Fund, Bob Lamkin of Bay Angels, Dan Myer from Pt. Judith Capital and Jeff Morrill from NuOrtho Surgical.

NuOrtho Surgical Inc. showcased their Tissue PreservationTM platform that is focused on the Orthopedic market place. CEO Jeffrey Morrill outlined their three product platforms of Soft Tissue Treatment, Agent Delivery and Bone Fusion and how they have been successful in building their business in a touchy economic climate. The most critical component is having a realistic plan with strategies to focus on. For NuOrtho, that included identifying a starting point from which to commercialize their whole platform building upon soft tissue treatment for cartilage. While there is the game changing capability of Bone Fusion, NuOrtho is establishing a product that will actually be used in their future platforms and will generate revenue sooner with this approach. An educational animation of how the cartilage treatment works can be seen at www.NuOrtho.com.

Dr. Louis Petrovic, the Director of the UMASS Advanced Technology and Manufacturing Center commented, “We are delighted that SNEEF showcased one of our more exciting Tech Venture Center companies. NuOrtho is doing innovative, creative, and exciting work that we expect will make it economically successful and that we believe will lead to jobs for U.MASS Dartmouth students and South Coast residents.

Morrill stated the Forum was productive in several ways including initiating conversations with strategic partners, investors and potential employees. We also recognized how much we have accomplished in one year as we shared our story including two additional issued patents bringing the total for NuOrtho to 9 – a great accomplishment for a start up. A big part of our success is the ability to operate in a strategic incubator like the ATMC. We would not be where we are without them.

July 7, 2009 - NuOrtho Surgical Featured at Medtec Investor Conference

Fall River, MA; July 7, 2009 - NuOrtho Surgical was a featured speaker at the recent Medtec Insights IN3 investor conference in Boston. The conference is the largest East Coast Strategic Partnership and Investment Meeting for Medical Technology Executives.

NuOrtho Surgical Inc. showcased their Tissue Preservation platform that is focused on the Orthopedic Surgeon marketplace. CEO Jeffrey Morrill outlined their point of entry product for soft tissue debridement and contouring. The technology has tremendous potential and is the foundation for their patented game changing technology for Bone Fusion. The potential to fuse bone together instead of using plates and screws has broad applications in the orthopedic marketplace and beyond. This opens up the ability to go beyond just bone fillers and grafts.

Morrill stated the conference was productive in opening up strategic conversations with existing ortho players as well as some looking to enter the space.

June, 2009 - USPO Issues Seventh Patent to NuOrtho Surgical

The USPTO has issued a new patent to NuOrtho Surgical, their seventh issued patent. NuOrtho is a developer of surgical instruments that enable Tissue Preservation in the Medical arena. The company will help doctors be more effective and efficient in their soft and hard tissue procedures minimizing collateral damage. The company is headquartered in Massachusetts.

The patent is titled “Electrosurgery Devices”. The specific patent application extends the low energy RF foundation already established by NuOrtho for treating tissue within the body. Treatment options enabled by the new approach include therapeutic devices to effect advantageous tissue changes and enhance the overall healing response of tissues.

NuOrtho’s product portfolio in development includes instruments for debridement and contouring of soft tissue. One key application will be for articular cartilage in the knee. As people age and cartilage frays or basic activity cause tears, NuOrtho’s probe can smooth and contour tissue to help patients return to pain free mobility. A game changing product is their bone fusing technology for hard tissue. This has the potential to eliminate the use of some plates and screws in basic procedures in orthopedics, Cranial Maxilla Facial and even the Veterinary arena.

Dr. Brant Bair, Chair of NuOrtho’s advisory panel sees tremendous potential for NuOrtho’s product portfolio. As an active tri-athlete and Orthopedic surgeon, he sees the benefits of Tissue Preservation for active people and the aging population. “The technology has the ability to advance the science of Orthopedic surgery and the team is laser focused on getting the first product to market.”

NuOrtho is focused on the US marketplace for initial launch. They will expand into the EU with partners. The company has recently opened a Series B round for strategic partners.

March, 2009 - Medical startup looking to expand in city

Financing in this economic climate is hard to come by for businesses, homeowners, car owners and municipalities alike, but a Fall River company that makes probes for hospitals to repair joint tissue has received $1 million from private investors and hopes to unveil its products within a year.

NuOrtho Surgical, a startup growing with the help of the incubator at the Advanced Technology and Manufacturing Center, is looking for space in Fall River and could hire 100 workers in the next three years, said President Jeffrey Morrill.

NuOrtho, whose founders also includes an orthopedic surgeon in New Mexico and a research and development expert in California, moved into the ATMC last October as it received its sixth patent. It plans to use the $1 million in financing, which it announced Tuesday, to file an application to the Food and Drug Administration and to prepare manufacturing capabilities for a product launch early next year.

The probes, about 1-foot-long and powered by an outlet, will be used for surgery for injuries or lesions on knees and shoulders and is designed to leave less damage on cartilage than the probes used now, Morrill said. Wayne Auge, the orthopedic surgeon, and Roy Morgan, the chief development officer, have been developing the probes since 2002.

NuOrtho’s growth plan includes $10 million in sales next year, $240 million in 2012 and $335 million by 2013. The probes will be marketed toward the 16,000 orthopedists in the United States. Morrill said they hope to expand to Europe and ultimately sell across the world.

The NuOrtho probes — there will be 12 variations — are similar to what’s on the market today, Morrill said, but lower temperatures and energy levels — called subplasma — allow NuOrtho probes to leave a smoother contour. “No one is working in exactly what we’re doing,” he said.

The probes, which would sell for around $250, are “relatively simple” devices, Morrill said, but are advanced enough that a bone-welding probe could eliminate the need for screws or plates for the most severe injuries.

FDA approval is expected by the end of 2009 or early next year.

The company considered locations in the Boston area, greater Minneapolis and northern California, said Morrill, who has lived in the area for about four years. They chose the ATMC for the help it gives to startups and ventures, he said. “Any time we look at a market, we look at the labor pool there, could it meet our needs? We felt Fall River was a good fit for that.”

February 12, 2009 - NuOrtho Surgical Completes Initial Tissue Testing

NuOrtho Surgical announced today that it has successfully completed tissue testing with its first device. "I have used the device and it exceded all performance expectations", says Brant A. Bair, MD, an orthopedic surgeon and NuOrtho Advisory Panel Chairman.

January 15, 2009 - M2D2 Supports NuOrtho Surgical

The Massachusetts Medical Device Development Center (M2D2), a medical device support team located at UMASS Lowell and Worchester is doing their part in helping rebuild our economy by supporting the innovative technology of NuOrtho Surgical. The M2D2 program develops and facilitates early stage medical device companies to ensure their success in New England. Dr. Jeremy Stern, a leading orthopedic surgeon on the South Coast, comments that NuOrtho's cartilage probe's ability to treat cartilage without causing side effects (like necrosis--killing of healthy tissue) has tremendous commercial application. It would be the holy grail." NuOrtho has raised initial funds to build their cartilage probe and is looking for help as they shift from the R&D to the commercialization phase. The initial funding has come from surgeons and device industry people who see the need and value the product has for patients. Dr. Stern: "NuOrtho has a broad list of patented products that will enable them to be the next great orthopedic company in Massachusetts."

January 14, 2009 - NuOrtho Surgical and BC Tech Announce Partnership

BC Tech: "NuOrtho Surgical is a medical device start up focused on Tissue Preservation for Orthopedic surgeons and their patients. Their innovative technology leverages a low level of Radio Frequency energy to restore mobility in patients by preserving healthy tissue during surgical procedures. We're proud NuOrtho Surgical selected BC Tech to assist in commercializing this therapy and look forward to a successful product launch."