ONKOS SURGICAL’s 3rd annual partnership with MSTS kicks off at the AAOS annual meeting in New Orleans

ONKOS SURGICAL’s 3rd Annual Partnership with MSTS Kicks Off at the AAOS Annual Meeting in New Orleans

Onkos Surgical® has renewed our diamond level sponsorship with the MSTS for 2018. This marks the second year of our partnership with the society. Onkos continues to focus our innovation initiatives in three areas: 1) infection management, 2) aseptic loosening and 3) soft tissue management.

Our sponsorship of the MSTS is another strong signal that Onkos is committed and aligned to the msts mission of advancing the science of orthopedic oncology and promoting high standards of patient care through excellence in education and research.

Patrick Treacy, Onkos CEO and Cofounder said, “our partnership with the MSTS is a foundational investment for Onkos Surgical. Collaboration with the society and its membership is critical for our team to understand the unique challenges orthopedic oncologists and their patients face. It is this dialog that will provide the necessary insights we need to truly innovate for this community of surgeons and patients.” Abu Muhammad, Society Director for the MSTS, said, “we are pleased to partner with Onkos Surgical at the Diamond level. The mission of our organization cannot be realized without the generous support of our sponsors. We look forward to working with the team at Onkos.”
 


ONKOS IN THE NEWS

ONKOS SURGICAL® and 3D Systems Team To Advance Personalized Surgical Oncology Solutions

PARSIPPANY, NJ, March 6, 2018 -Onkos Surgical, Inc. Announced today that it signed a 4-year agreement with 3D Systems (NYSE:DDD) to advance the delivery of personalized surgical solutions and help improve patient outcomes. The agreement provides Onkos Surgical priority access to 3D Systems’ VSP® (Virtual Surgical Planning) Orthopedic product line for surgical planning, as well as 3D printed anatomical models. Additionally, the companies will collaborate on next-generation 510(k) clearances for 3D printed implants and instruments for tumor reconstruction.

Through this partnership, the companies aim to advance the delivery of personalized surgical solutions to help improve outcomes for patients with tumors and lesions occurring in the pelvis and long bones (i.e., the large bones found in the arms and legs) associated with musculoskeletal cancers. The combination of VSP and 3D printing allows surgeons to preoperatively plan a surgical procedure, as well as design surgical tools and implants for each patient’s unique case.

Established by 3D systems, VSP technology received FDA market clearance for the cranio-maxillofacial region as a service-based approach to personalized surgery, combining expertise in medical imaging, surgical simulation and 3D printing. The surgeon initiates the process, bringing their clinical knowledge and desired surgical plan to an online web meeting with a 3D systems biomedical engineer to simulate and plan the surgical procedure. The outcome is a digital plan that is transferred to the operating room via accurate 3D printed patient-specific models, guides and templates.

“We are delighted to announce this partnership with 3D Systems, a true visionary and leader in medical device 3D printing and surgical planning,” said Patrick Treacy, co-founder and chief executive officer, Onkos Surgical. “As an early stage investor in Onkos, they understand the criticality of our connection to the customer, the unique challenges these surgeons and patients face and the tremendous opportunity we have to make a difference for these patients while building a high value and scalable business.”

Onkos surgical was founded in 2015 to deliver high quality implants and instruments that meet the unique needs of musculoskeletal tumor patients. The company quickly embraced 3D printing as a technology that could address the particular needs of both the cancer patient, and the cancer surgeon. Onkos surgical realized the profound impact they could make if they combined personalized 3D printed medical devices and instrumentation with patient-specific surgical simulation.

“When we launched our Precision Oncology initiative at MSTS 2017 in Denver, it was met with great enthusiasm from the surgeon community,” said Sean Curry, senior vice president of commercial operations, Onkos Surgical. “The relationship with 3D Systems enhances our capabilities with product bundles and patient-specific solutions that will deliver on our promise of bringing focus and dedication to this space.”

“3D Systems is pleased to partner with Onkos Surgical delivering adaptive tools designed to provide insights, processes and outcomes for musculoskeletal oncology cases,” said Kevin McAlea, executive vice president, general manager, Metals and Healthcare, 3D Systems. “The combination of VSP and 3D printing provides an advantage for surgeons to personalize the surgical plan, instruments and implants for each unique case.”

According to the NIH – National Cancer Institute (cancer.gov), there were 3,260 new primary bone cancer cases reported in 2017. In addition to chemotherapy and radiation, two common surgical options for musculoskeletal cancer patients are amputation and limb salvage. Through limb salvage, the surgeon removes the cancer and some healthy tissue with the goal of leaving the limb largely intact. The section of bone that was removed can be replaced either with a bone graft from the patient or another person, or with an internal prosthesis (i.e., implants) made of metal and other materials.


Forward-looking statements

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward looking statements can be identified by terms such as “believes,” “belief,” “expects,” “may,” “will,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings “forward-looking statements” and “risk factors” in the company’s periodic filings with the securities and exchange commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise.

About 3D Systems

Systems3D Systems provides comprehensive 3D products and services, including 3D printers, print materials, on demand manufacturing services and digital design tools. Its ecosystem supports advanced applications from the product design shop to the factory floor to the operating room. 3D systems’ precision healthcare capabilities include simulation, virtual surgical planning, and printing of medical and dental devices as well as patient-specific surgical instruments. As the originator of 3D printing and a shaper of future 3D solutions, 3D Systems has spent its 30-year history enabling professionals and companies to optimize their designs, transform their workflows, bring innovative products to market and drive new business models. More information on the company is available at www.3dsystems.com.


ONKOS SURGICAL® Announces Major Milestone with First Patient Entered in the Onkos Registry

PARSIPPANY, NJ, March 8, 2018 -Onkos Surgical, Inc., a specialty medtech company dedicated to advancing innovation for the surgical oncology market, announced today that Dr. Steven Gitelis and Rush University has entered the first patient in the Surgical Oncology Registry Team (SORT™) or Onkos’s Registry. SORT™ is a multicenter, cloud based, HIPAA compliant platform designed to prospectively collect functional, psychosocial and oncological outcomes.

“This is a major milestone for Onkos and the musculoskeletal oncology community of surgeons and patients. When we started our company, we made a commitment that we would place a large investment in collecting prospective outcomes in this space,” said Patrick Treacy CEO and co-founder of Onkos Surgical. “SORT™ is a cloud-based platform that will allow surgeons to collect prospective data and collaborate with other institutions to drive larger data sets. We are the first and only company to invest in a registry of this kind and we believe this database will allow clinicians to answer meaningful questions that may lead to improved patient outcomes.”

Steven Gitelis, MD, Onkos Surgical Chief Medical Officer and Surgeon in Chief and Director, Section of Orthopedic Oncology at Rush University said, “This is an unprecedented opportunity for my musculoskeletal oncology colleagues to collaborate in a way that will answer important questions. The Onkos Registry provides a research platform that will enable individual institutions to prospectively collect their own data while partnering with other leading institutions around the country to answer questions that will potentially impact how we treat patients in the future. In the past, small data sets have impacted the ability to truly change the paradigm of patient care. This registry has the potential to change that.”

“We have several leading cancer institutions around the country who are interested in this platform,” said Jerry D’Alessio, Onkos VP of R&D and Advanced Engineering. We spent a tremendous amount of time perfecting the protocol and analytical tools to enable surgeons to prospectively assess functional, psychosocial and oncologic outcomes. The cloud-based platform allows the surgeons to design prospective studies and enables patients to participate in the analysis of their outcomes. We are excited to expand this registry over the coming year.”

Mr. Treacy added, “Onkos has made a commitment to musculoskeletal oncology. We continue to make investments that will advance innovation and we know that our singular and dedicated focus to this group of surgeons and patients may lead to meaningful improvements in patient care.”


ONKOS INNOVATION SERIES

ONKOS SURGICAL® Tackles Significant Clinical Challenge: Aseptic Loosening

Aseptic loosening of endoprostheses continues to be a substantial clinical challenge for orthopedic oncologists and the patients they treat1. While improvements in implant design have helped, surgeons continue to search for new solutions to solve for aseptic loosening in a patient population with compromised healing potential2. Fortunately, there have been technological advances such as additive manufacturing (3D printing) and methods to apply hydroxyapatite (HA) to three-dimensional pore structures that may help to address this clinical challenge.

A recent publication by Mumith et al. Suggests there are opportunities to obtain improved fixation for endoprostheses with the use of stems designed to incorporate porous metal extracortical collars. This is significant, considering a large number of patients with distal femoral and proximal tibial endoprostheses require a revision due to implant loosening3. The results of this research provided two key insights for future implant designs to potentially address this challenge. First, the authors found that optimal tissue ingrowth is heavily dependent on pore size. Second, they noted that HA coatings, when deposited on a porous metal implant in a manner such that the implant remains porous, can have hydrophilic properties. This allows the implant to absorb and deliver blood or other biological fluids to the endogenous, healthy bone at the implant interface. The research concluded that a collar design with a specific porosity to maximize bone ingrowth, coupled with a HA coating applied in this certain way, may promote extracortical bone bridging1.

Onkos Surgical is currently focused on three distinct clinical areas of innovation aligned with the most common failure modes of limb salvage implants: 1) Infection, 2) soft tissue management and 3) aseptic loosening1. We have invested heavily in developing experience and expertise in 3D printing and application of HA. We believe, combined with our singular focus on providing solutions for musculoskeletal oncologists and their patients, this provides us with the ability to develop new implant designs to address aseptic loosening.

We have also partnered with clinicians at leading cancer institutions to guide our development initiatives. We are specifically interested in understanding the clinical factors that impact patient outcomes and the nuances of the surgical workflow to optimize or efficiency. In a recent meeting with Shervin Oskouei, MD, Assistant Professor of Orthopedic Surgery at Emory University School of Medicine, we discussed his thoughts on aseptic loosening and implant design.

Dr. Oskouei, can you share your thoughts on the challenges associated with aseptic loosening in your patient population?

“Similar to the results in arthroplasty patients, implants used in oncology applications have a high failure rate due to aseptic loosening. Especially as patients survive longer, I suspect we will continue to see a rise in failures from loosening.”

What are some implant design factors that you believe are important in minimizing this complication?

“The reduction of polyethylene wear debris and inability of polyethylene debris to gain access to the canal of the long bone in oncology implants is crucial. Similar to the findings in the Mumith study, there is merit in providing a solution where the collars will be able to be matched to the patients’ cross sectional diameter for ideal fit and bone ingrowth. I think we need to look to biologic fixation of our implants to bone as an ideal way to reduce aseptic loosening including press-fit stems to allow a biologic fixation with constant remodeling of the implant-bone interface.”

At Onkos, we are currently focusing development efforts on a family of stems with HA coating to address the clinical challenge of loosening (figure 1). We believe this may have the potential to provide an optimal environment for bone and soft tissue attachment, improve extracortical fixation, and reduce the incidence of implant revisions due to loosening.

The products described in this article are not cleared by the FDA for commercial use in the United States.

Fig. 1. Optimized pore structure with HA deposition. Representative image, not available for commercial sale in US.

References:
1. Eric R. Henderson, et al. Failure Mode Classification for Tumor Endoprostheses: Retrospective Review of Five Institutions and a Literature Review. The Journal of Bone & Joint Surgery. Volume 93-A d No.5, March 2, 2011.

2. P.S Unwin, et al. Aseptic Loosening in cemented custom-made prosthetic replacements for bone tumors of the lower limb. The Journal of Bone and Joint Surgery. Volume 78-B, No.1, January 1996.

3. A. Mumith, et al. Augmenting the osseointegration of endoprostheses using laser-sintered porous collars. The Bone & Joint Journal. Volume 99-B, No.2, February 2017.


ONKOS SURGICAL® Featured in MedTech Strategist

Key points

• The musculoskeletal oncology market has long been a niche of a niche, woefully under-served by large orthopedic companies, which often forces surgeons to improvise the tools and implants they need to treat patients.

• Launched just over two years ago, Onkos Surgical is building a company focused exclusively on this segment, basing its business on a deep relationship with surgeons who have historically felt ignored by product companies.

• The company has been able to move quickly and efficiently by embracing a strategy it calls “specialty medtech” as well as a novel approach to manufacturing using 3D printing. It is also building through partnerships, including one with 3D pioneer 3D Systems.

• Onkos is already thinking of ways it can expand its business, but perhaps its greatest challenge: proving to this often-neglected customer base that it’s different from other orthopedic companies and that its commitment to the field is real.

To read this January issue of the MedTech Strategist featuring Onkos Surgical go to: http://onkossurgical.com/onkos_medtech_article_1-31-18.pdf


ONKOS PRODUCT HIGHLIGHT

uDesign™ Patient Solutions

uDesign Patient Solutions is a consultative, concierge level service provided by ONKOS SURGICAL. uDesign brings the level of expertise and surgical planning you demand in complex cases to each and every one of your cases. The interactive experience enables a personalized planning approach for each patient allowing you to better manage your outcomes.

My3D™ Technologies

Differentiated service model to support My3D personalized solutions:

  • Cloud based platform for surgeon to share imaging and create a digital surgical plan.
  • With Onkos assistance, surgeon creates a simulated surgical experience and plan.
  • Engineers create a suggested plan based on surgeon’s desires.
  • Includes a suite of capabilities.

Sample uDesign™ Surgical Plan


ONKOS ADVOCATES

Onkos Surgical is committed to help raise awareness of sarcoma and pediatric cancer through fundraising activities, support of cancer research, and partnerships with organizations and regulatory agencies to advocate for change that will impact the lives of cancer patients.

Sarcoma Foundation of America
According to its website, “The mission of the Sarcoma Foundation of America (SFA) is to advocate for sarcoma patients by funding research and by increasing awareness about the disease. The organization raises money to privately fund grants for sarcoma researchers and conducts education and advocacy efforts on behalf of sarcoma patients.” To learn more about the Sarcoma Foundation of America please visit www.curesarcoma.org

American Cancer Society
According to its website, “At the American Cancer Society, we’re on a mission to free the world from cancer. Until we do, we’ll be funding and conducting research, sharing expert information, supporting patients, and spreading the word about prevention. All so you can live longer—and better.” To learn more about the American Cancer Society please visit www.cancer.org


ONKOS SURGICAL® Participates in Race to Cure Sarcoma 5K Run

On November 12, 2017, Onkos employees participated in a 5K charity run to support sarcoma awareness. The event was sponsored by the Sarcoma Foundation of America-New Jersey and was well attended with over 100 participants. All proceeds were donated to the Sarcoma Foundation to advance research for musculoskeletal disorders. Despite the temperature being a bit chilly, everyone participating enjoyed supporting a great cause


ONKOS SURGICAL® Participates in Jersey Mike’s “Month of Giving” Initiative

On March 8th, ONKOS employees joined in on Jersey Mike’s Subs 8th Annual Day of Giving. Each year, “approximately
1,360 Jersey Mike’s restaurants donate 100 percent of sales to the local charities.” This year the make-a-wish foundation is the charity of choice at the Jersey Mike’s near the Onkos home office in Parsippany, NJ. According to its website, “over $6 million was donated to local charities” based on collections at each of the locations. At Onkos we continue to honor our commitment to support local and national organizations who share in making a difference in peoples lives. For more information, go to: www.jerseymikes.com/mog/charities