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Orthofix Announces Exclusive US License for IGEA’s Bone and Joint Stimulation Devices

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Orthofix to pursue FDA approval of IGEA’s solutions to expand the Company’s US Bone Growth Therapy offerings

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix, Inc.. (NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced they have entered into an exclusive license agreement to commercialize the innovative portfolio of Italy-based IGEA S.p.A’s bone, cartilage and soft tissue stimulation products in the U.S and Canada.

Under terms of this agreement, Orthofix has the rights to pursue U.S Food and Drug Administration approvals and commercialization of IGEA’s platform of orthopedic products, which are not currently available in the U.S. These products, which will be marketed under the Orthofix brand, will expand Orthofix’s bone growth therapies portfolio of Pulsed Electromagnetic Field (PEMF) products with additional treatment modalities and indications such as Low-Intensity Pulsed Ultrasound (LIPUS) and Capacitive Coupling (CC) for fracture management. The license also includes innovative, new technology applications designed to address joint inflammation, pain, and cartilage protection.

“Orthofix is the U.S. market leader with our PEMF technology bone growth stimulation systems indicated for post-operative spinal fusions and treating bone fractures that have not healed after surgery, and IGEA is the European market and technology leader for bone and joint stimulation,” said Orthofix President and Chief Executive Officer Jon Serbousek. “Combined, these portfolios will enable us to offer physicians and patients additional treatment solutions for fracture management and complement our pursuit of new indications for managing soft tissue and joint health such as our ongoing rotator cuff repair IDE clinical study.”

Founded 40 years ago at the University of Modena, Italy, IGEA is a leader in the manufacturing and distribution of bone and joint cartilage stimulation systems which include stimulation modalities of LIPUS, PEMF and capacitive coupling. Outside of the U.S. more than 20,000 patients are treated every year with their products.

“As a company with a long history of treating patients in Europe, we are excited to enter into this agreement that will expand the availability of our bone and joint cartilage systems to patients in the U.S.,” said IGEA President, and founder Dr. Ruggero Cadossi. “Aligning with Orthofix’s expertise and distribution in the stimulation market enables us to provide even more physicians access to our innovative products to improve patient outcomes.”

About Orthofix
Orthofix Medical Inc. is a global medical device and biologics company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 70 countries via the Company’s sales representatives and distributors. For more information, please visit www.Orthofix.com.

About IGEA
IGEA is committed to research in the area of clinical biophysics developing innovative medical devices for therapeutic purposes. IGEA focuses on orthopedic applications for bone and cartilage healing and oncologic applications for drug and gene electrotransfer. IGEA products are distributed in all European countries through distributors or its subsidiaries. For more information, please visit www.igeamedical.com.

Forward Looking Statements
This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Form 10-K”). In addition to the risks described there, factors that could cause or contribute to such differences may include, but are not limited to: the risk that FDA approvals may be delayed or not be obtained; the risk that surgeons may be slow to adopt the IGEA orthopedic products; the risk that future patient studies or clinical experience and data may indicate that treatment with the IGEA orthopedic products does not improve patient outcomes as much as previously believed, or otherwise call into question the benefits of its use to patients, hospitals and surgeons; the risk that the product may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that insurance payers may decline to reimburse healthcare providers for the use of our products.

This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

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Source: https://www.biospace.com/article/releases/orthofix-announces-exclusive-us-license-for-igea-s-bone-and-joint-stimulation-devices/?s=93

Medical Devices

Ryan Reed to Compete for GMS Racing at Darlington Raceway

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Ryan Reed will pilot the No. 24 Tandem Diabetes Care Chevrolet Silverado at Darlington Raceway this Friday reports GMS Racing officials.

Ryan Reed said, “I’m so excited and I can’t thank Chevy and everyone at GMS, Mike (Beam) and Maury (Gallagher), enough for the opportunity.” He added, “It is awesome to see a new partner come into the sport with Tandem Diabetes Care. I use their t:slim X2 insulin pump to help manage my type 1 diabetes and their advanced Control-IQ technology has improved my health overall. It’s incredible to be able to represent them on the track and have my daily life changed by their product.”

A new partner in NASCAR, Tandem Diabetes Care is dedicated to making the lives of people with diabetes better through relentless innovation and revolutionary customer experience.

“We are thrilled that Ryan (Reed) is experiencing the benefits of the t:slim X2 pump with Control-IQ technology, and couldn’t be more excited to support him in following his passion,” said John Sheridan, President and CEO, Tandem Diabetes Care. “We’re constantly hearing from customers about how our technology is changing lives and we believe that Ryan getting behind the wheel this weekend is yet another example of these positive outcomes.”

“We’re very grateful to have talented drivers like Ryan (Reed) to be able to step up and compete for us,” said Mike Beam, President of GMS Racing. “We’re thankful for him and his partner Tandem Diabetes Care for coming on board with us for Darlington.”

The No. 24 Tandem Diabetes Care Chevrolet Silverado will make it’s on-track debut in the LIftKits4Less.com 200 at Darlington Raceway on Friday, May 7. The race will be broadcast live on FS1 and MRN.

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Source: https://infomeddnews.com/ryan-reed-gms-racing/

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Medical Devices

Ryan Reed to Compete for GMS Racing at Darlington Raceway

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Published

on

Ryan Reed will pilot the No. 24 Tandem Diabetes Care Chevrolet Silverado at Darlington Raceway this Friday reports GMS Racing officials.

Ryan Reed said, “I’m so excited and I can’t thank Chevy and everyone at GMS, Mike (Beam) and Maury (Gallagher), enough for the opportunity.” He added, “It is awesome to see a new partner come into the sport with Tandem Diabetes Care. I use their t:slim X2 insulin pump to help manage my type 1 diabetes and their advanced Control-IQ technology has improved my health overall. It’s incredible to be able to represent them on the track and have my daily life changed by their product.”

A new partner in NASCAR, Tandem Diabetes Care is dedicated to making the lives of people with diabetes better through relentless innovation and revolutionary customer experience.

“We are thrilled that Ryan (Reed) is experiencing the benefits of the t:slim X2 pump with Control-IQ technology, and couldn’t be more excited to support him in following his passion,” said John Sheridan, President and CEO, Tandem Diabetes Care. “We’re constantly hearing from customers about how our technology is changing lives and we believe that Ryan getting behind the wheel this weekend is yet another example of these positive outcomes.”

“We’re very grateful to have talented drivers like Ryan (Reed) to be able to step up and compete for us,” said Mike Beam, President of GMS Racing. “We’re thankful for him and his partner Tandem Diabetes Care for coming on board with us for Darlington.”

The No. 24 Tandem Diabetes Care Chevrolet Silverado will make it’s on-track debut in the LIftKits4Less.com 200 at Darlington Raceway on Friday, May 7. The race will be broadcast live on FS1 and MRN.

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Source: https://infomeddnews.com/ryan-reed-gms-racing/

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Medical Devices

Oura raises $100M, looks to add more health features to sleep-tracking ring

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Oura, a startup making a sleep-tracking ring, raised $100 million in funding. Photo credit: Oura

With wrist-based heart monitors, algorithms to detect arrhythmias, and a growing number of health features, most wearable-makers are looking to reach a broader group of adopters than gadget fans and fitness enthusiasts.

Oura, a company making a sleep-tracking ring, is no exception. The company is involved in clinical trials to see if its device could be used to detect early signs of illness, or track fertility, based on users’ temperature and heart rate.

The startup recently raised $100 million in funding, which it plans to invest across all parts of its business, including hardware, software, marketing and customer experience. New investors that participated in the funding round include Temasek, JAZZ Venture Partners, Esai Co., and Elysian Park Ventures, the investment arm of the LA Dodgers.

“These funds provide Oura with substantial runway for important future opportunities,” CEO Harpreet Singh Rai wrote in a blog post.

The startup was founded in Finland in 2014, and has raised $148 million to date, according to Crunchbase. Oura’s tiny wearable device includes two infrared LED sensors, body temperature sensors and an accelerometer to track users’ activity, sleep and heart rate.

The price, at $300, is less minuscule, though it’s about on par with smartwatches that measure similar metrics. To date, Oura said it has sold about 500,000 rings.

During the pandemic, many wearable-makers tested to see if their devices could play a role in predicting or preventing the spread of disease. For example, a virtual study by the Scripps Research Translational Institute found that changes in sleep, activity levels and heart rate could be used to identify Covid-19 cases — when paired with symptom data.

Researchers at UC San Francisco evaluated Oura for a similar purpose, to see if its temperature sensors could be used to monitor fever. They published initial results in Nature from the first 50 participants, showing that a rise in temperature did correlate with self-reported fever symptoms, though the study is still ongoing.

More broadly, Singh Rai said he plans to invest some of the new funds into helping people better understand what to do with their health data.

“But when we say wearable device — we don’t just mean tracking your steps,” he wrote. “People want more and need to know what to do with their data and how to take action toward understanding their health and improving it.”

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Source: https://medcitynews.com/2021/05/oura-raises-100m-looks-to-add-more-health-features-to-sleep-tracking-ring/

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Medical Devices

Design Transfer: A practical Approach

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In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where the specifications are basically transferred to the manufacturing environment to ensure the device can be manufactured at large scale. 

The transfer of design specifications to manufacturing can start in the early phase of the design process, when during the design of the products elements that can support manufacturability are integrated into the design of the product. 

In the next sections, we will review the main requirements associated to the design transfer for the most important quality system regulations.

Requirements according to FDA Quality System Regulation (QSR)

In the context of FDA regulation, the requirements associated to Design Transfer are mentioned in the section 21 CFR 820.30

Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

As mentioned above, there must be a procedure that defines the strategy for the translation of design specifications into production specifications; this procedure can be part of the design control procedure. Moreover, the procedure should explain how the final review and approval of design and development activities are performed, in order to transfer the design to manufacturing. 

It is also very important that in the procedure there are specific guidelines for the preparation of the design master record, with the list of documents that should be included in the Device Master Record. 

Usually production specifications are written documents that could be assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications. However, also other types of documents such as training materials, digital data files and other types of files.

Requirements according to ISO 13485:2016

The requirements associated to ISO 13485:2016 are reported in the section 7.3.7 of the standard. Specifically, this section of the standard reports: 

The organization shall document procedures for transfer of design and development outputs to manufacturing. These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements. Results and conclusions of the transfer shall be recorded. 

These requirements are not that different from the ones mentioned in the FDA regulation. Of course, it is necessary to verify that the design outputs are suitable for manufacturing before to place the device on the market. 

MDSAP Requirements for Design Transfer (DT)

No specific differences for MDSAP requirements than the ones already described in the sections before. One remark for the Anvisa requirements for design transfer: it is requested that the design is not released for production until the responsible performed the review of the contents of the design history file, to make sure the documentation is complete and aligned with the dedicated design plan. 

The release of the design and related approval by the assigned person shall be documented. 

Design Transfer (DT) and Manufacturing Process Validation

The design transfer and the validation of the manufacturing process are activities strictly linked one to each other. Typically, the design transfer can be concluded when the validation efforts for the manufacturing process are concluded. The modalities through which validation is performed can depend from the internal process of the organization; typically it is necessary to have three small consecutive batch of products used to perform validation activities of the manufacturing process.

Design Transfer and Design Validation

Design transfer and Design Validation are the last two steps of the design process. Thus, it is necessary to conclude the DT when the validation of the design is concluded. If we take in consideration the classical V model for the design process, we see there are different levels of requirements. The highest level is the one that shall be checked to ensure that the whole design process is validation.

design

Design Transfer Checklist 

QualityMedDev has prepared a DT checklist that it is possible to download to ensure the completion of the design transfer activities. The checklist can easily be used at the end of the DTprocess to check that all the activities have been properly performed and documented and that the design process is ready to be transferred to the manufacturing. 

Design Transfer for Software

Design transfer for software means, in general, providing documentation and tools that allow the incorporation of the software into the product. 

Usually it can be necessary to have a copy of the releases software and specific procedures or working instructions to ensure it is possible to have copies of the software. 

Usually design transfer is happening after a software release as when the software release is occurring, we are still at the design phase. This is specifically through for embedded software which needs to be deployed at manufacturing site in order to be transferred. 

For software as a medical device, it is slightly different as there is no hardware support for these types of software. In this case the release of the software and the design transfer can basically occurred at the same time. 

QualityMedDev Newsletters

QualityMedDev is an online platform that provides extensive support to medical device manufacturers and consultancy companies in the field of regulatory compliance. We publish blog posts on quality management system and regulatory-related topics and provide extensive documentation ready to be downloaded to support the implementation and maintenance quality system or product-related certifications.

We publish as well a periodic newsletter aimed at sharing information on the new articles or documents which have been made available through QualityMedDev website.

If you would like to stay updated with the last news and analysis from the regulatory world for medical device sector, do subscribe to our newsletter by filling the form below.

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Source: https://www.qualitymeddev.com/2021/05/06/design-transfer/

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