Smith+Nephew, the global medical technology business, announces that it has agreed to acquire the Extremity Orthopaedics business of Integra LifeSciences Holdings Corporation for $240 million. The acquisition supports Smith+Nephew’s strategy to invest in higher-growth segments.

This acquisition will significantly strengthen Smith+Nephew’s extremities business by adding a combination of a focused sales channel, complementary shoulder replacement and upper and lower extremities portfolio, and an exciting new product pipeline.

The focused extremities commercial channel includes a specialised sales force and distributors, predominantly in the US as well as Canada and Europe.

The portfolio is highly complementary to Smith+Nephew’s existing orthopaedics offering, in particular providing entry into the shoulder replacement and foot and ankle segments. The full portfolio includes devices, implants, and instruments which provide for shoulder replacement as well as reconstruction of bone in the hand, wrist and elbow (Upper Extremity) and foot and ankle (Lower Extremity). The US extremities segment has been growing at around 6-7% per annum1.

The Extremity Orthopaedics R&D pipeline includes a next-generation shoulder replacement system, which is expected to be ready for full commercial launch in 2022.

Skip Kiil, President, Global Orthopaedics at Smith+Nephew, said:

“Integra’s Extremity Orthopaedics business is an established global player in the rapidly growing extremities segment, including total shoulder replacement, and has a well-regarded specialised sales channel and a strong pipeline of new products. This strategic acquisition represents a significant opportunity to strengthen Smith+Nephew’s position in a high-value area and allows us to offer a leading extremities portfolio to customers.”

Peter Ligotti, Senior Vice President, Extremity Orthopaedics, Integra LifeSciences, said:

“We are looking forward to joining an organisation that is committed to growing and expanding its orthopaedic product portfolio. We are excited for the opportunities ahead as we continue to advance orthopaedic innovations for our customers and improve patient outcomes.”

The business operates from facilities in Austin, Texas, which includes a surgeon training facility, as well as in Lyon, France. It is expected that around 300 employees will join Smith+Nephew on completion.
Transaction details

The value of the transaction is $240 million which will be financed from existing cash and debt facilities.

The business generated revenue of $90 million in 2019 and traded at a small loss. The business is expected to deliver double-digit revenue growth and be slightly dilutive to trading profit in 2021 and 2022. The Return on Invested Capital (ROIC) is expected to meet or exceed our Weighted Average Cost of Capital (WACC) by the fifth year.

The acquisition is expected to complete around the end of 2020, subject to the satisfaction of customary conditions including consultation with employee representative bodies.

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business that exists to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,500+ employees deliver this mission every day, making a difference to patients’?lives through the excellence of our product portfolio, and the invention and application of new technologies across?our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.1 billion in 2019. Smith+Nephew is a constituent of the FTSE100. The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc?and its consolidated subsidiaries, unless the context requires otherwise.

iWEECARE, the developer of the world’s smallest continuous temperature monitoring product, Temp Pal, announced that it raised US$2.4 million in extended pre-series A financing. TransLink Capital, a Silicon Valley-based venture capital firm with a specific focus on Asia, led the round of fundraising. Spurred on by the COVID-19 pandemic and the subsequent need for remote patient monitoring, notably in fever detection, the Taiwan-based healthtech company plans to address the demand and achieve higher levels of public safety.

The round also saw investment from Taiwan’s National Development Fund, BE Capital, Taiwan Surface Mounting Technology Corp (TSMT), NCTU Angel Club, Might Electronic, and existing investors Verge HealthTech Fund and Darwin Venture.

iWEECARE’s flagship product Temp Pal, a remote wearable thermometer initially developed to assist in pregnancy planning and baby care has received medical certification in Europe, Singapore, Thailand, and Taiwan. In light of the ongoing Covid-19 pandemic and the key role that body temperature plays in early detection and prevention, Temp Pal has been rapidly adopted in hospitals and for home quarantine management.

The Temp Pal has already been deployed in Mainland China, Ireland, Japan, Thailand, and Taiwan as an effective solution to mitigate the risk of infection and reduce the burden on health systems by reducing the physical contact between caregivers and their patients.

The funds will be used to accelerate marketing activities to address the demand for remote patient monitoring technologies in the United States and China. iWEECARE’s co-founder and CEO, Glen Tseng said, “Temp Pal received an overwhelming amount of inquiries for coronavirus use from the US and China earlier this year. The new funding will be used in accelerating our global footprint to satisfy the demands from these markets and ultimately improve patient safety and outcomes.”

“We are positive about iWEECARE’s business, that’s why we started investing in the promising healthtech startup from last June,” said Jackie Yang, TransLink Capital co-founder. “Under the COVID-19 pandemic and shift to remote patient monitoring, we see huge potential for iWEECARE to expand globally. We hope the new investment can help the brand to develop and establish an international presence.”

Arthur Chen, the Executive Director of BE Capital at Taiwan Tech Arena (TTA), a healthcare-focused venture capital firm in Taiwan, said, “We received positive feedback from clinicians of Show Chwan Memorial Hospital and are confident Temp Pal can be a world-class product.”

“iWEECARE’s remote thermometer has received good press during the COVID-19 pandemic with its capabilities to detect, monitor, and record patients’ real-time temperature. Our investment is to help iWEECARE expand its footprint in the global remote healthcare market,” said Churchill Chen, CEO, NCTU Angel Club.

Might Electronics is an electronics service provider and with the investment has become iWEECARE’s manufacturing partner. Ray Tai, the CEO of Might Electronics said “We’re happy to engage iWEECARE’s growth with the investment and become the startup’s manufacture partner by satisfying ISO 13485 Medical Devices Quality management systems standards. We will soon expand Temp Pal’s shipment and help more people all over the world.”

With the advent of the digital age, we are no longer required to attend pharmacies and medical stores in person, and rather, we afforded the luxury of ordering them from the comfort of our homes – to our front doors. Buying medical supplies online is, on the whole, quite safe, providing you are sensible and avoid unscrupulous and dangerous websites. Unfortunately, not everyone is astute enough to discern a fraudulent website from a genuine one, which can cause big problems if phoney or improperly made medical supplies are ordered and used.

This page will hopefully alleviate some of the confusion that shrouds buying medical supplies online and will tell you some mistakes to avoid when you are buying medical supplies digitally – whether they be medication, wound dressings, or other medical-related equipment. By following this guide, you will be able to ensure your safety when shopping online and will be able to guarantee that you always buy the genuine article, and never fall victim to organized crime groups that prey on the not-so-digitally-savvy. Online medical fraud is a huge industry and one that nets organized crime groups billions of dollars every single year – so be wary.

Buying medical supplies online, are you? Here are some mistakes to avoid.

Buying Without Research

Everything bought online requires research – unless you are repeatedly buying the same item or have experience with the e-commerce website you are buying from. Buying items without research can yield terrible results. Internet review sites exist solely to notify consumers of  unprofessionalism on the part of the seller. If you do not consult reviews or research, you may find yourself buying from a fraudulent seller who sells you phoney products. The medical review specialists of CPOE.org explain that reading reviews and researching can help you to make smart medical decisions. Research everything that you are buying online, consult review sites and be careful.

Too Good to Be True? It Probably Is

When it comes to the internet, while you can get great deals and huge savings, cheap medical supplies are often fraudulent. Medical supplies are expensive to manufacture and produce – and while you can, as just mentioned, find great deals on them, anything that is drastically reduced (shall we say over 50%) is likely a misrepresentation or fraud. When it comes to medication online, sophisticated organised crime gangs mass-produce fake medication, sometimes with harmful chemicals, and sell them at incredibly discounted prices. If you have found a deal online that seems too good to be true – avoid it like the plague.

Unlicensed Pharmacies

Unlicensed pharmacies are often the work of elusive organised crime groups who target and prey on people who are sick and reliant on medication. Unlicensed pharmaceutical websites should be avoided at all costs, lest you wind up very unwell. There have been recorded instances of consumers ingesting poisons sold as pharmaceutical drugs. The groups that mastermind these websites are often the same groups who manufacture and market large quantities of controlled drugs throughout the world. These groups care little for the health of the user of their phoney products and are simply interested in netting as much profit as is possible. You can check out whether or not pharmacies have been licensed through research – and this is definitely something you will want to do when buying any drugs online.

Buying Second-Hand

Buying second-hand medical supplies is another questionable venture. It of course varies on what it is that you are buying. If you are buying a bed, wheelchair, or medical equipment designed to help with mobility, providing the equipment is in good condition (or can be refurbished) you should be okay. It is when you begin purchasing medication and drugs from people second-hand that you enter into a grey area. Technically, buying medication (or selling it on) is considered distribution of a controlled drug – providing it was acquired through a prescription. You should avoid anybody selling their drugs lest you wind up involved in a drug distribution conspiracy or fall victim to fraudulent medication.

Gratuitous Buying

The internet affords us the option to buy more or less anything at any time. Medical supplies, especially during the current global pandemic, are in short supply. Gratuitously buying medical supplies to stockpile is something you should avoid. You could, if you do buy supplies unnecessarily, wind up depriving someone who is desperately in need of the supplies from them. Buy only what you need, and do not feel it necessary to hoard PPE (personal protective equipment), as so many are doing all around the world.

With the help of this page, you should now be better adept at handling online medical supplies. Purchasing medical supplies online can be a risky topic if you are not educated on what is considered a mistake, and what isn’t. This page should have cleared all of that up for you.

Paragonix Technologies announced that its Paragonix SherpaPak Cardiac Transport System (CTS) for donor heart preservation and transport is now being used by Stanford Health Care, the first heart transplant center on the West Coast of the United States to implement the system as standard of care for its heart transplant program.

The first donor heart preserved by Stanford Medicine practitioners using the Paragonix System set a record for the longest recovery — transported across the country by jet and safeguarded for 283 minutes.

Enabling long-distance heart recoveries is an important capability to ensure patients on transplant waitlists can get the heart they desperately need. The Paragonix SherpaPak CTS was designed to provide a controlled environment for donor hearts en-route to patients, a radical advancement from conventional methods.

“We are honored to be part of the life-saving work being accomplished at Stanford,” said Bill Edelman, CEO of Paragonix Technologies. “There are more people in need of heart transplants than there are hearts available. This drives our team’s unyielding commitment to provide a reliable, safe preservation environment for organs undergoing the transplant journey.”

As per the Organ Procurement and Transplantation Network, 36,527 organ transplants were accomplished in the United States in 2020. Regenerative medicines plays a vital role in transplants as it refers to an interdisciplinary field and is a branch of translational research that applies engineering and life science principles to promote regeneration, and can potentially restore diseased and injured tissues as well as whole organs. Apart from organ regeneration, regenerative medicines are effective in cell therapy, gene therapy, and tissue engineering, and are applicable in cardiology, oncology, dermatology, and ophthalmology.

Owing to higher prevalence of chronic diseases, genetic diseases, and aging population, causing a higher requirement for organs and biomaterials for tissue regeneration, the regenerative medicine market has escalated to be valued in between $26 billion-$27 billion as of 2020. The analyst of this business intelligence report has tracked this developing marketplace to be progressing economically at a CAGR of 22%-24% during the forecast period 2020-2025.

Regenerative Medicine Market Outlook:

According to Global Burden of Disease, a study by WHO, musculoskeletal conditions are the second highest contributor to global disability. And, Institute for Health Metrics and Evaluation (IHME) has revealed that the total burden of disability increased by 52% between 1990 and 2020.

Gene therapy and tissue engineering in orthopedic surgery endures to assist as the foundation for innovative treatments of innumerable musculoskeletal disorders. Regenerative medicine market is all established to capitalize on the global musculoskeletal disorder rate as it assists in tissue engineering and therapy. Due to such occurrences, orthopedic & musculoskeletal cases dominate the application segment and is flourishing with an application CAGR of 21%-23% going through 2025.

After an acute analysis of the regional aspects of regenerative medicine market, North America has been located as the leading region encapsulating under its terrain around 30%-32% of the global regenerative medicine market demand. The sheer affluence of this region can be attributed to several facts.

The United States with its existing modern and cutting-edge healthcare infrastructure is compatible for intricate medical outputs such as stem cell and oncology research augmenting regenerative market. Accelerating frequency of ailments, for instance cancer and diabetes, in the United Sates is positively affecting the market. National Cancer Institute estimated the nationwide expenses for cancer care in the United States in 2020 were $147.3 billion.

Similarly, 23.1 million folks in the United States are diagnosed with diabetes at a cost of more than $245 billion per year. Awareness among population regarding the available stem cell procedures and therapies effectively curing cancer and diabetes is increasing, which consequence in increasing the demand for the regenerative medicine market.

Gilead Sciences, Inc. and Eisai Co., Ltd. (Tokyo, Japan) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.

Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for the product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in RA. The companies will jointly commercialize the medicine to make it available to physicians and patients across Japan.

“Despite progress in the treatment of RA, existing therapies have not enabled many patients to reach the treatment goals recommended in clinical guidelines. There continues to be a need for effective and well-tolerated new treatment options,” said Tsutomu Takeuchi, MD, Professor of Internal Medicine and Chief of Rheumatology at the School of Medicine, Keio University. “Jyseleca is a new JAK inhibitor that, in clinical trials, has demonstrated clinical improvement, low disease activity and clinical remission in a broad patient population, including patients with inadequate response to biologics.”

“RA causes many patients debilitating fatigue and pain that can significantly interfere with their daily lives,” said Yoshiya Tanaka, MD, Professor at First Department of Internal Medicine, University of Occupational and Environmental Health. “It is important to have new treatment options that can offer patients effective symptom control and bring them new hope.”

The approval in Japan is based on robust clinical trial results from the global FINCH Phase 3 and DARWIN Phase 2 programs. The FINCH and DARWIN programs evaluated Jyseleca in more than 3,500 patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with standard of care including biologic DMARDs. Patients receiving Jyseleca once daily showed improvements in clinical signs and symptoms, decreases in disease activity, and less progression of structural damage in their joints. Across the FINCH trials, Jyseleca demonstrated a consistent safety profile, and the frequency of adverse events of interest (including serious infections, herpes zoster, venous thromboembolism, and major cardiovascular events) was comparable to control groups.

Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were 0.2 percent and 0.3 percent, respectively. The exposure adjusted incidence rate of serious infections per 100 persons per year (95 percent CI) was 1.7 percent (1.3, 2.1) in the Jyseleca 200 mg group and 2.5 percent (1.9, 3.3) in the Jyseleca 100 mg group, respectively. When prescribing Jyseleca, physicians are advised to monitor patients for the development of new, or exacerbation of existing, serious infections including pneumonia, tuberculosis, sepsis, and other viral infections.

“This regulatory approval recognizes the benefit that Jyseleca may be able to provide people living with RA who have not been successfully treated with prior therapies and represents an important advance in the treatment of this challenging disease,” said Luc Hermans, MD, President and Representative Director, Gilead Sciences, K.K.

“Now that Jyseleca has received approval in Japan, we look forward to leveraging our extensive experience in clinical development and commercialization in the RA area in Japan to bring this new treatment option to patients across Japan as soon as possible, and contribute to the improvement of patients’ quality of life,” said Hidenori Yabune, President of Eisai Japan, Senior Vice President, Eisai.

Gilead is developing Jyseleca in collaboration with Galapagos NV (Mechelen, Belgium (Nasdaq and EuroNext: GLPG)). The two companies are conducting global studies investigating the potential role of Jyseleca in a variety of diseases, including the previously reported Phase 3 SELECTION trial in ulcerative colitis.

About the FINCH Program

The FINCH Phase 3 program investigated the efficacy and safety of filgotinib 100 mg and 200 mg once-daily, in RA patient populations ranging from early-stage to biologic-experienced patients. FINCH 1 was a 52-week, randomized, placebo- and adalimumab-controlled trial in combination with MTX, enrolling 1,759 adult patients with moderately to severely active RA who had an inadequate response to MTX. The primary endpoint in FINCH 1 was ACR20 at Week 12. The trial included radiographic assessment at Weeks 24 and 52. FINCH 2 was a global, 24-week randomized, double-blind, placebo-controlled, Phase 3 study evaluating filgotinib on a background of the conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) among 449 adult patients with moderately to severely active RA who had not adequately responded to biologic DMARDs (bDMARDs). The primary endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52-week, randomized trial in 1,252 MTX-naive patients to evaluate filgotinib 200 mg alone and filgotinib 100 mg or 200 mg combined with MTX versus MTX alone. The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial included radiographic assessment at Weeks 24 and 52.

Hormone replacement therapy HRT has a variety of uses for patients with different health concerns and needs. Examples of HRT include progesterone therapy, estrogen therapy, testosterone therapy, and human growth hormone (HGH) therapy. Due to the usefulness of HRT in improving the physical conditions of patients who undergo such therapy, it can even be considered as a medical necessity. However, there is a catch – the HRT cost is typically prohibitive, and you will most likely need health or medical insurance to help cover the cost.

Not all health insurance policies include HRT in their coverage, which is why you must know if your health insurance covers HRT.

Know the Significance of Coverage

It’s not just enough that you know the definition of coverage. By the time the insurance policy is provided to you by the insurance company or its representative, it is wise to pay attention to the explanations they provide and ask questions. Thoroughly read the terms and conditions of the policy of your insurance plan. You should also be aware that the extent of insurance coverage varies with every insurance company and state. State federal laws can affect the way people can acquire health insurance and the extent of the medical costs covered. In Florida, for example, there are various ways you have access to the best insurance plans in Florida, such as through health insurance marketplaces, through private insurance providers, or an employer’s plan. Thanks to the Affordable Care Act (ACA) or Obamacare, health insurance can be bought at a low and affordable cost, and public programs like Medicaid and CHIP can help people get insurance coverage. Blue Cross Blue Shield (BCBS), Aetna, and Cigna are some of the best insurance providers in Florida that have flexible and extensive plans and coverage.

Look into Your Summary of Benefits and Coverage

Most insurance plans have a Summary of Benefits and Coverage (SBC) part in a printed insurance plan policy. The SBC can also be accessed online if you have an online account with your insurance company. This is an important source of information that lists the services covered by the health insurance plan and how much of the costs are covered.

Look for the List of Covered Drugs

With most insurance providers going for paperless insurance transactions, you must open an online account with your insurance provider. It is a more convenient way of checking the status of your health insurance plan and for checking the updated list of covered drugs by the plan. You can check if growth hormone supplements are included in the list. These supplements are part of HRT medications but can be recommended or prescribed for certain medical conditions or as a medical intervention for proper health or recovery after surgery or a major health complication.

Check the Plan’s Accredited Doctors

Looking for physicians, specialists, facilities, and clinics covered by your health insurance plan can help determine if HRT is included in the plan’s coverage. Many of us may think that male testosterone boosters are not medically prescribed supplements and thus do not need a doctor’s prescription. While it’s true that there are OTC testosterone products available in the market, getting one of the doctors in your plan’s network coverage can not only ensure that you are getting the right supplement and dosage, but they can also help you find ways to spend less on these supplements.

Your plan’s accredited doctors or network can also help you get regular consultations about your health and well-being. They can help refer you to other doctors and specialists that are also part of the covered network of the insurance who can recommend or perform HRT for men and women. They can also refer you to accredited clinics or medical facilities that provide HRT services. Some plans have broad and flexible coverage terms, which can make it possible for doctors to include HRT as necessary medical therapy for the health and well-being of the patient. To be sure about the inclusion of HRT in the plan’s coverage, you also need to check with the insurance provider.

Hormone replacement therapy is taking a more important role in the health of patients. It is no longer considered as a body-building or gender-realignment therapy, but also as a necessary preventive and recuperative medical treatment for conditions like menopause, osteoporosis, heart disease, and certain types of cancer. It is only a matter of time before states will unanimously consider HRT to be a part of the coverage of all types of health insurance.