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An advisory panel working for US Food and Drug Administration split evenly on the decision to whether to approve a first of its kind oral medication for treating Type 1 diabetes. The committee is undecided about the approval with a vote 8-8 and has left the decision to the agency by the end of March 2019.

The drug sotagliflozin made by drug makers Lexicon and Sanofi Pharmaceuticals is planned to be sold under the brand name Zynquista. The medication which is to be taken along with insulin came under increased scrutiny owing to certain severe side effects of the medicine. The drug poses a higher risk to patients in developing diabetic ketoacidosis. Diabetic ketoacidosis (DKA) is a condition where the body doesn’t produce enough insulin leading to high blood sugar and highly acidic substances called ketones. It’s a serious life-threatening complication for Type 1 diabetic patients. The risk of developing DKA has led many reviewers to vote against the drugs release.

In Type 1 diabetes the body doesn’t produce insulin, so people with the condition have to regularly monitor their blood sugar levels from rising beyond a certain limit. Type 1 Diabetes often called juvenile diabetes is usually diagnosed early in childhood. People with the condition are treated with insulin but it often leads to fluctuation in blood sugar levels causing much discomfort. The proposed Zynquista drug is a one-time daily drug which helps manage the patient’s blood sugar level, however it reduces the blood sugar levels by excreting excess sugar into urine.

The drugs approval process was based on three clinical trials which involved around three thousand patients. The results found that there were about 56 cases of patients developing DKA among 1,748 patients, or 3.2 percent while the placebo test showed that 5 patients developed DKA among 1,229 patients or 0.4 percent. The drug trials brought significant benefits to the patient including reduced blood sugar, some weight loss and lowered blood pressure.

The panel members were aware of the risk involved in DKA which has often led to serious hospitalization and death and raised concerns about the higher risk involved in real world adoption of the drugs outside the confines a clinical trial. A panel member who voted against the drug, Dr. Jack Yanovski said that the smaller degree of benefits may not outweigh the increased risk it may pose to the patient. Other panel members disagreed by stating that the patients are in desperate need of the Zenquista drug.

There are about 1.25 million people in USA suffering from Type 1 diabetes and 40,000 are diagnosed every year, according American Diabetes Association. The companies said that they would continue to work towards approval of the drug with USFDA.

A London-based digital health startup Kaia Health has raised $10 million in Series-A round of funding which offers app based training for chronic pain management. The startup founded in 2015 provides ‘mind-body therapy’ to patients suffering from musculoskeletal disorders. The idea is to offer mobile technology based alternative therapy which includes medical education, psychological techniques and guided physical exercises.

The CEO and co-founder of Kaia Health, Konstantin Mehl said that the app is useful for chronic pain patients suffering acute pain for 2-3 days. He said that as the physical therapy for pain management is usually expensive because of physiotherapist fees, only 2% of patients suffering acute pain receive any kind of professional help while the rest 98% extensively rely on pain killers and surgery. The treatment is very ineffective as well as expensive.

Mr. Mehl said that the traditional therapy for chronic pain management includes the patient receiving a one-on-one physiotherapy session for weeks. The patient has to visit the physiotherapist personally and has to pay handsome fees. Instead of this hassle, Kaia Health has developed a personal trainer app which uses computer vision technology to provide guided exercise and pain management techniques by a fully autonomous exercise coach. The app visually monitors the user as they are performing the exercises and gives vocal feedbacks if they are wrongly doing a certain move or exercise.

Kaia’s goal is to reduce the use of pharmaceuticals for pain relief as over-prescription of opioid drugs have escalated into a nationwide epidemic and rise in the number of opioid overdose deaths. The app based approach gives flexibility to users for exercise timings. As many people don’t like to go to physiotherapist every time for an exercise session and also don’t find it comfortable to practice at home without instruction, the app based monitoring helps them get live feedback.

The company released an app called Squat Challenge which taught an exercise called squat, only to see how people use the technology. And then the startup tracked all possible body positions to provide improvising suggestions. It took nearly six months to track all body positions and now Mr. Mehl claims that they have successfully added all the body positions. He added that the app now can correct any exercise and movements on millimeter basis.

Competitors in the app-based pain management field includes another startup Hinge Health. Their approach also involves an app along with wearable sensors to monitor body movements, however quite different from Kaia’s automated sensor free AI approach. Mehl said that they have tried working with wearable sensors but found that users are usually disinclined towards putting sensors on body while doing exercises. As a result they decided against the use of sensors and relied more on Artificial Intelligence based personal training.

The Series-A round of investment was led by Balderton Capital. The new funding will be used to scaling up in the USA with new office in New York.  Kaia is currently used by 250,000 users in Europe and USA.

A senior analyst at Future Market Insights (FMI) traces challenges and scope for improvements with the current products in the breast pump market.

Exclusive breast feeding for babies up to 6 months of age has been recommended by healthcare experts, globally. Moreover, babies with congenital defects or premature births also are unable to consume breast milk without difficulty. These difficulties faced by new mothers and the increasing operations of breast milk banks are encouraging the adoption of hospital grade breast pumps around the world.

What shortcomings of conventional breast pumps must manufacturers focus on?

Unlike other equipment that people use on a regular basis, such as automobiles or smartphones, the breast pump has not seen any significant improvements in the recent past. Most breast pumps come with the challenges of having multiple complex components that need to be assembled or taken apart for functioning the right way, while being very noisy. Moreover, conventional breast pumps are usually made with a one size fits all configuration. This approach by manufacturers so far has been detrimental to the growth of the breast pump market, as mothers are often seen choosing the weaning of their baby as opposed to using breast pumps owing to lack of convenience.

What are some notable innovations made by breast pump manufacturers to address such challenges?

Willow Inc. is one of the few breast pump manufacturers that has released breast pump products that makes its operation easy and completely silent. The device is almost completely automated and can work on a single charge for an entire day, without any effort from the user, while analyzing the timing and milk production rate of the woman to optimize its own operation for better results. In addition, the product is also integrated with its own smartphone app, for essential data about the new mother’s health.

On a similar note, the Massachusetts Institute of Technology has developed a number of innovations to change how breast pumps are designed. For instance one prototype makes use of air bladders instead of vacuum systems that enhance noise reduction.

Also, Medela a leader in the breast pump technology has started to experiment with different sucking patterns that imitate the nursing behavior of real babies to optimize performance during different stages of lactation for women.

Are there any significant threats to the current breast pump adoption scenario?

Rapidly improving quality of alternative methods of lactation are anticipated to restrict the production and sales of breast pumps. For instance, galactogogues, which are medications for inducing milk production in new mothers, are increasingly moving away from synthetic ingredients to natural counterparts, which are just as effective in their function. Such efforts are witnessing high preference by mothers, and are expected to pose significant challenges to breast pump manufacturers.

Need more revelations and stats? Then checkout a sample of the FMI report.

A senior market analyst at Future Market Insights talks about the ongoing changes taking place in the negative pressure wound therapy market and the major innovations developed by service providers.

Owing to advances in medical treatments, the advent of negative pressure wound therapy (NPWT) has become essential in the treatment of various health issues including pressure ulcers, diabetic ulcers, burns, and venous ulcers among others, through devices that can be customized for the unique contours of every patient’s body. This is expected to set up lucrative prospects for the future of NPWT service providers.

Is treating chronic diabetes with NPWT more effective?

The cost of treating wounds arising through chronic diabetes can be very high, owing to ancillary expenses related to the purchase of regular changes of dressings, visits to outpatient facilities, and hospitals. Traditional treatment methods usually require more outpatient visits and surgical procedures in comparison to NPWT processes in the long term. While negative pressure wound therapy has a higher initial cost, faster recovery rates can shorten the treatment duration and save money and resources for both the patient, as well as the healthcare institution.

What innovations in NPWT device design will have a significant impact on treatment processes?

Manufacturers are increasingly integrating mechanically powered systems, and miniature sizes of device designs to improve on portability and ease of application. While, design changes were not found to make any significant improvement in recovery time, these smaller devices allowed for faster application, while having minimal negative impact on the daily activities of patients, which makes it ideal for patients who have smaller wounds, who can go about their lives without being restricted in the movement in any notable way.

In addition, the recent addition of a silver coating to the conventional antimicrobial foam dressings has decreased microbial growth, thereby reducing the duration of hospital stays, or surgical debridement procedures in the pelvic region or the body’s extremities.

Do NPWT treatments pose risks to patients, further hampering its adoption?

As per research conducted by the Food and Drug Administration of the United States, the use of negative pressure wound treatment can be counterproductive when used for certain types of wounds and ailments. Untreated osteomyelitis, necrotic tissues with scabs, malignant wounds, exposed nerves or organs, and nonenteric fistulas are some of the conditions where the use of NPWT devices and procedures can create a risk of severe bleeding and reduction of coagulation, posing significant risks to the patient’s life. This might have an adverse effect on the use of such treatments. However, the right healthcare training for physicians, can help in not only the accurate evaluation of wounds, but also the entire patient, before the administration of NPWT.

Need more revelations and stats? Then checkout a sample of the FMI report.

According to WHO, nearly 1.35 million people lose their lives as a result of road crashes and between 20 to 50 million people suffer fatal injuries, where several injuries lead to disability. The prevalence of traumatic injuries around the world, more of which result in severe damage to the body’s musculoskeletal system resulting in loss of function has created the demand for expert assistance. Orthopedic trauma devices are a significant element in the surgical treatment of traumatic orthopedic injuries.

With the increasing incidents of road accidents and severe fractures, the demand for orthopedic trauma devices is expected to rise predominantly. In addition, the increasing prevalence of osteoarthritis and rheumatoid arthritis are more likely to influence the demand for orthopedic trauma devices.

3D Printing Advancements to Reinforce Orthopedic Trauma Devices Demand

Technological advancements are greatly benefitting various sectors, with the increasing consumer preference shift toward easy accessibility, convenience, and improved productivity enabled by the integration of technology. The healthcare sector has also gained major advantages with improved patient care and better treatment management owing to the incorporation of technology.

Cutting-edge technologies such as the 3D printing are amongst the most effective development that boosts the capabilities of healthcare offerings. The manufacturers of orthopedic trauma devices are incorporating 3d printing technology for creating implants that are trending in recent times. Manufacturers of orthopedic trauma devices are seeking regulatory approvals to further commercialize the 3D printed orthopedic trauma devices.

Additive Orthopaedics, for instance, who is a well-known manufacturer of orthopedic trauma devices, recently gained approval from the FDA for its 3D printed locking lattice plates that are designed in patient-specific fashion. With this clearance, the company can now utilize the 3D printed plate for the stabilization, alignment, and fusion of fractures, along with arthrodesis and osteotomies of small bones such as those in ankle and foot.

The incorporation of 3D printed technology for manufacturing patient-specific orthopedic trauma devices is expected to provide improved outcomes in the near future, owing to which 3D printing technology acts as a major growth driver for the orthopedic trauma devices ecosystem.

Key Developments

New products introduced in the orthopedic trauma devices space reflect the potential held by the future, as leading manufacturers of orthopedic trauma devices are gaining traction by expanding their product portfolio with innovative orthopedic trauma devices.

• A recognized musculoskeletal solutions provider, Globus Medical, Inc. expanded its portfolio of orthopedic trauma devices with the addition of two new products including the ANTHEM® Proximal Humerus Fracture System and the ANTHEM® Ankle Fracture System. The new products are introduced with an aim to design systems that assist in increasing versatility, streamlining procedures, improving patient care and minimizing the operative time.
• A medical device company Panther Orthopedics, Inc. recently unveiled its FDA-approved innovative flexible fixation device, the PUMA System for clinical use, which is a novel approach for the syndesmotic fixation, offering stable fixation with no post-operative loss of fixation. The PUMA System is a revolutionary advancement in treating orthopedic injuries, which provides the advantages of flexible fixation devices and screws without the drawbacks they hold.

Recent Clinical Trial to Reflect Future Scope in Hip Fracture Fixation

Hip fracture treatment in elderly patients remains a major public health priority. Hip injuries are often treated with the help of surgery. The factors such as pre-existing arthritis, osteoporosis, age, overall health, and level of activity contribute to the type of surgical fixation performed. Addressing the socio-economic concern of treating hip fractures in elderly patients, a leading medical device company, X-Bolt Orthopaedics designed its X-BOLT innovative hip fracture device.

Granted an approval by FDA for marketing the product in the United States, the device is designed to redefine the conventional surgical treatment and reduce the rate of re-operation. The company announced the completion of the year-long follow-up of the 1000^th patient included in the multi-center randomized controlled trial that compared the extracapsular hip fracture fixation devices. It is claimed to be the largest clinical trial in hip fracture fixation. Such developments are expected to further drive the orthopedic trauma devices landscape towards a potential future.

The ongoing technological advancements coupled with burgeoning research activities are together, expected to strengthen the future potential staged by the orthopedic trauma devices landscape. A sample of the market study on the orthopedic trauma devices market shines light on such future opportunities.