On August 24, 2021 Medtronic plc (NYSE:MDT) reported financial results for its first quarter of fiscal year 2022, which ended July 30, 2021 (Press release, Medtronic, AUG 24, 2021, View Source [SID1234586861]).

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Key Highlights

"FY22 is off to a strong start – Q1 reflects solid execution and continued procedure recovery." – Chairman & CEO Geoff Martha

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Revenue of $8.0 Billion Increased 23% Reported and 19% Organic
GAAP Diluted EPS of $0.56; Non-GAAP Diluted EPS of $1.41
Company Reiterates FY22 Revenue Guidance; Raises Lower End of FY22 EPS Guidance by 5 cents
The company reported first quarter worldwide revenue of $7.987 billion, an increase of 23% as reported and 19% on an organic basis, which excludes the $245 million benefit of foreign currency translation. Revenue growth rates have not been adjusted for the negative impact of the extra selling week in the first quarter of last fiscal year. The company’s first quarter results reflect a strong recovery from the impact of the COVID-19 pandemic on elective procedures that the company experienced in 2020. Unless otherwise stated, all revenue growth rates in this press release are stated on an organic basis, which excludes the impact of foreign currency translation.

As reported, first quarter GAAP net income and diluted earnings per share (EPS) were $763 million and $0.56, respectively, increases of 57% and 56%, respectively. As detailed in the financial schedules included at the end of this release, first quarter non-GAAP net income and non-GAAP diluted EPS were $1.908 billion and $1.41, respectively, increases of 128% and 127%, respectively.

First quarter U.S. revenue of $4.101 billion represented 51% of company revenue and increased 22%. Non-U.S. developed market revenue of $2.601 billion represented 33% of company revenue and increased 20% as reported and 11% organic. Emerging Markets revenue of $1.286 billion represented 16% of company revenue and increased 31% as reported and 25% organic.

"Fiscal 2022 is off to a strong start with our first quarter results coming in ahead of our expectations, reflecting solid execution and continued procedure volume recovery, with most of our businesses at or above pre-COVID levels," said Geoff Martha, Medtronic chairman and chief executive officer. "In addition, we drove market share gains across a number of our businesses, including three of our largest: Cardiac Rhythm Management, Surgical Innovations, and Cranial & Spinal Technologies. Looking ahead, we have some big opportunities in front of us, with near-term milestones in both our renal denervation and surgical robotics businesses. These opportunities, combined with the broader investments we’re making in our pipeline, set us up well to accelerate our top line growth."

Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Cardiovascular first quarter revenue of $2.890 billion increased 19% as reported and 15% organic, driven by low-twenties organic growth in SHA, mid-teens organic growth in CRHF, and high-single digit growth in CPV.

Cardiac Rhythm & Heart Failure first quarter revenue of $1.483 billion increased 19% as reported and 15% organic. Adjusting for the discontinuation of HVAD System sales, CRHF revenue increased 19% organic. Cardiac Rhythm Management revenue increased in the high-teens, driven by low-double digit growth in Defibrillation Solutions and low-twenties growth in Cardiac Pacing Therapies, including low-thirties growth in Leadless Pacemakers on the continued global adoption of the Micra transcatheter pacing system. Cardiac Ablation Solutions revenue increased in the low-thirties on strong adoption of Arctic Front Advance cryoballoon catheters and consoles. Cardiovascular Diagnostics revenue grew in the low-double digits.
Structural Heart & Aortic first quarter revenue of $787 million increased 26% as reported and 21% organic. Structural Heart grew in the high-thirties, driven by mid-thirties growth in transcatheter aortic valves (TAVR), including high-forties TAVR growth in the United States. Cardiac Surgery increased in the high-teens. Aortic declined in the low-single digits, as the financial impact of the previously announced global recall of the Valiant Navion thoracic stent graft system offset low-twenties growth in abdominal aortic aneurysm (AAA) stent grafts.
Coronary & Peripheral Vascular first quarter revenue of $620 million increased 11% as reported and 7% organic. Coronary & Renal Denervation (CRDN) declined in the low-single digits, given the impact of previously announced coronary tenders in China. Excluding China, CRDN revenue grew in the high-single digits. Peripheral Vascular Health increased in the low-twenties, with mid-teens growth in IN.PACT drug-coated balloons and mid-fifties endoVenous growth on strong sales of VenaSeal and ClosureFast superficial vein products and Abre venous stents.
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. Medical Surgical first quarter revenue of $2.322 billion increased 29% as reported and 25% organic, with high-thirties organic growth in SI and mid-single digit organic growth in RGR.

Surgical Innovations first quarter revenue of $1.554 billion increased 44% as reported and 39% organic. The division had low-forties growth in Vessel Sealing and high-thirties growth in Advanced Stapling, driven by the continued adoption of the company’s LigaSure, Sonicision, and Tri-Staple technologies. Hernia & Wound Management increased in the mid-thirties, with strength in sutures and hernia product lines.
Respiratory, Gastrointestinal & Renal first quarter revenue of $768 million increased 7% as reported and 3% organic. Patient Monitoring increased in the mid-twenties, with mid-thirties growth in the company’s Nellcor pulse oximetry products. Respiratory Interventions decreased in the mid-twenties, with sales of ventilators declining in the low-forties as demand returns to pre-pandemic levels. Gastrointestinal revenue increased in the high-twenties on low-fifties growth in Esophageal & Gastric. Renal Care Solutions increased in the mid-single digits with strong growth in acute therapies.
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Neuroscience first quarter revenue of $2.204 billion increased 29% as reported and 26% organic, with high-thirties growth in Neuromodulation and Specialty Therapies and high-teens growth in CST, all on an organic basis.

Cranial & Spinal Technologies first quarter revenue of $1.123 billion increased 19% as reported and 17% organic. Spine & Biologics grew in the low-double digits and Neurosurgery increased in the low-twenties, as spine surgeons continue to adopt the Medtronic ecosystem of spine implants and enabling technology, including Mazor robotics, StealthStation navigation, O-arm imaging, and Midas Rex powered surgical instruments.
Specialty Therapies first quarter revenue of $641 million increased 42% as reported and 37% organic. Neurovascular increased in the high-single digits and ENT increased in the mid-thirties. Pelvic Health increased 134%, driven by continued strong adoption of the InterStim Micro sacral neuromodulation system.
Neuromodulation first quarter revenue of $440 million increased 40% as reported and 37% organic. Brain Modulation increased in the high-thirties, driven by the launch of the Percept PC deep brain stimulation system. Pain Therapies increased in the low-forties, with Targeted Drug Delivery revenue more than doubling on the backlog recovery of replacement procedures, and Pain Stim revenue growing in the mid-twenties on strong uptake of Intellis with DTM SCS therapy. Interventional grew in the low-twenties.
Diabetes
Diabetes first quarter revenue of $572 million increased 2% as reported and declined 3% organic. Diabetes quarterly revenue performance was driven by high-single digit growth in durable pumps, including strong growth in international markets on the continued launch of the MiniMed 780G system. This was offset by mid-teens declines in U.S. sales of consumables and continuous glucose monitoring (CGM) products.

Guidance
The company today reiterated its revenue growth guidance and raised the lower end of its EPS guidance range for fiscal year 2022.

The company continues to expect revenue growth in its fiscal year 2022 to approximate 9% on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2022 would be positively affected by approximately $100 to $200 million.

The company increased its fiscal year 2022 diluted non-GAAP EPS guidance from the prior range of $5.60 to $5.75 to the new range of $5.65 to $5.75, including an estimated 5 to 10 cent positive impact from foreign currency exchange versus a 10 to 15 cent positive impact previously.

"We’re reiterating our revenue guidance for the year while increasing the lower end of our EPS range on the back of our first quarter results," said Karen Parkhill, Medtronic chief financial officer. "We remain focused on accelerating our long-term revenue growth and generating strong returns for our shareholders. In addition to growing our dividend, we are increasing our investments at the front end of major product launches, growing our R&D spend broadly across the company, and executing disciplined tuck-in acquisitions."

Webcast Information
Medtronic will host a webcast today, August 24, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at news.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Medtronic plans to report its fiscal year 2022 second, third, and fourth quarter results on November 23, 2021, February 22, 2022, and May 26, 2022, respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
The first quarter financial schedules and non-GAAP reconciliations can be viewed below. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the first quarter earnings presentation, click here.

On August 24, 2021 AdAlta Limited (ASX:1AD) and Carina Biotech Pty Ltd reported that thay have entered a collaboration agreement to develop next-generation i-body enabled CAR-T cells, with the potential to bring CAR-T cell therapy to treat a far greater range of cancers than the small number of blood cancers that has been achieved today (Press release, AdAlta, AUG 24, 2021, View Source [SID1234586859]).

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CAR-T cell therapy is a fast-emerging form of cancer therapy that modifies a patient’s immune system to recognise and attack cancer cells that have resisted standard treatments such as chemotherapy and radiation.

AdAlta’s CEO, Dr Tim Oldham commented, "We believe that by combining our i-bodies with Carina’s world-class CAR-T platform, we can make this important new therapeutic approach accessible to more patients and a greater range of cancers than is possible today. We are well past the starting line, having worked previously on the first two targets selected for our collaboration, and with Carina on one of these."

Carina’s CEO, Dr Deborah Rathjen commented, "This collaboration with AdAlta gives us the capability to generate bi-specific CAR molecules and then next-generation CAR-T cell products with enhanced cancer targeting and efficacy – something we are very excited about. The collaboration is off to a great start with Carina having already successfully inserted an AdAlta i-body into a CAR-T cell with functional cancer killing capability."

About the collaboration
Under the Collaboration Agreement, AdAlta will discover and optimise panels of i-bodies that bind to designated solid tumour antigen targets, from which Carina will generate bi-specific CAR-T cells and identify optimal CAR-T product candidates. Carina and AdAlta will jointly fund pre-clinical proof of concept studies in mouse tumour models.

The Collaboration Agreement contemplates commencing work on up to five tumour antigen targets during the next two years and will continue until completion of research on the final target. The first two targets have been selected enabling research to commence within the next three months. AdAlta’s initial contribution will leverage its established laboratory resources and is not anticipated to have a material impact on current cash runway.

AdAlta and Carina will jointly own the products developed through the collaboration. On a product-by-product basis: the companies may elect to continue to co-develop any product; out-license any product to third parties; or either company may exercise an option to license the other party’s share of the collaboration assets.

Dr Tim Oldham continued, "A core part of AdAlta’s strategy is to enter collaborations with partners where we can further the use of our i-bodies to address disease targets previously thought undruggable. The i-body-directed CAR-T cells will be the second example of this, complementing our collaboration with GE Healthcare where i–bodies are being used to deliver a PET imaging agent. The Carina collaboration contributes multiple potential products to our pipeline expansion goals."

AdAlta and Carina will host a Webinar to discuss the collaboration results at 2.30pm AEST Wednesday, 25 August 2021. Register here:
View Source;qzeohAXAGQ

About CAR-T cell therapy
Chimeric antigen receptor T cell (CAR-T) therapy is a revolutionary and targeted cancer treatment option that harnesses a patient’s own immune system to fight their cancer, providing a personalised cancer treatment. It was named by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) as its Advance of the Year in 2018.

Chimeric antigen receptors (CARs) are human-engineered molecules expressed on the surface of a patient’s T cells – key cells of the immune system. These CAR molecules are "targeted" at molecular markers on cancer cells. T cells armed with CARs (CAR-T cells) can more easily "home in" on cancer cells and destroy them.

There are already five approved CAR-T therapies available in the US today. These are generating transformational outcomes for patients with a small number of blood cancers that have failed multiple prior lines of therapy. Even with these limited early applications, the market is forecast to grow at 20.2% per year, and to be worth $20.3 billion by 2027[2] . Revenues from solid tumour CAR-T cell therapies are forecast to exceed revenues from blood cancer CAR-T cell therapies by 2030[3] .

About i-bodies
i-bodies are an example of a "next-generation antibody". Antibodies are large protein molecules playing a key role in the immune system’s response to the presence of a foreign substance (antigen). Next generation antibodies are smaller proteins engineered to replicate key functions of full-sized antibodies and are predicted to have a major impact on human health, particularly in oncology, autoimmunity and chronic inflammatory diseases[4].

AdAlta’s proprietary i-bodies are approximately one tenth of the size of conventional monoclonal antibodies. They were engineered using a human protein backbone and synthetic antigen binding regions to mimic small, very stable "single domain antibodies" found in sharks. The result is a range of unique and versatile proteins capable of interacting with high selectivity, specificity and affinity with previously difficult-to-access targets in the human body that have been implicated in many serious diseases.

Benefits of combining CAR-T and i-bodies
The small size and unique targeting of i-bodies provides greater flexibility and design options for CAR-T cells and are ideally suited for the production of bi-specific CARs with increased precision and efficacy. i-bodies can be utilised as the binding domain of a CAR receptor that engages the tumour antigen. i-bodies are approximately half the size of traditional binding domains and are capable of accessing and engaging antigens in unique ways.

On August 24, 2021 GenScript Biotech Corporation (HKEX: 1548.HK), a leading global technology and service provider of life science R&D and manufacture, reported its first half 2021 financial results for the six months ended June 30 (Press release, GenScript, AUG 24, 2021, View Source [SID1234586858]). It also announced that the Group has expanded its presence in the gene and cell therapy (GCT) industry, with aggressive investments from the Group’s life science services and products business, biologics CDMO business, and cell therapy business.

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In the first half of 2021, the Group maintained strong momentum across all business segments. Total revenue increased by 38% to USD 229.6 million, and gross profit increased by 28.1% to USD 138.6 million.

The Group’s non-cell therapy business revenue increased by 36.6% to USD 195.7 million, with gross profit of USD 104.7 million, a 23.0% YoY increase. This impressive success was driven by the launch of new products, advanced sales capability and capacity expansion, including its GCT CDMO business’ historic breakthrough in explosive revenue growth. This built on the Group’s early investments in the field and advantages in plasmid and lentivirus R&D and manufacturing solutions. For the Group’s cell therapy business, revenue increased by 46.8% YoY to USD 33.9 million, benefitting from continued recognition of its successes and milestone investments.

As the world’s No. 1 gene synthesis supplier, GenScript Biotech has been dedicated to the gene synthesis business for more than one decade and continues to hone its competitive edge in the field. It has laid a strong technical foundation for its GCT business, which also serves as a major revenue stream for the Group. As GenScript Biotech’s life science services and products business, biologics CDMO business, and cell therapy business are all achieving strong momentum and investing aggressively in the GCT industry, the Group’s is expanding its presence throughout the GCT value chain.

GenScript Biotech has been continuing its strategic investments in R&D and innovation. In the first half of 2021, R&D expenses increased by 51.6% YoY to USD 175.1 million. The non-cell therapy business invested about 10% of its revenue in GMP facility construction and other infrastructure expansion. The cell therapy business spent USD154.5 million on R&D, a 52.1% YoY increase, with an investment focus on clinical studies of cilta-cel and manufacturing facilities that support the business’ ongoing clinical trials and future commercialization.

GenScript Biotech is ushering in the rise of GCT as the next biotech industry revolution, tapping into the huge potential of CRO and CDMO platforms. Over the next two to three years, the life science business and biologics CDMO business will increase their strategic investments into the field. This includes investments in GCT-related ssDNA and sgRNA services, utilizing automation technology to upgrade production lines, and accelerate the launch of ongoing cell therapy products and R&D in new pipelines.

"While the global pandemic continues to impact the world and the life science community, GenScript Biotech was able to harness opportunity to maintain strong momentum. We especially made rapid progress GCT-related products and services, a key strategic field for the Group. This was made possible by our unwavering dedication to the frontier of life science technology and our market insights. As we look ahead, GenScript Biotech will continue to invest aggressively in the GCT industry to meet booming demand and fulfill our mission to make people and nature healthier through biotechnology," said Dr. Patrick Liu, Rotating CEO of GenScript Biotech.

First Half 2021 Business Highlights by Segment

The life science services and products business reported a remarkable boost in the first half of 2021. Revenue increased by 32.2% YoY to USD 152.0 million, and operating profit before unallocated central expenses and share based compensations increased by 25.5% to USD 55.2 million, maintaining great profitability.

The business has also further diversified. Gene synthesis services increased in cost efficiency, while services in protein, peptide, antibody and oligo businesses were also expanding fast, becoming the Group’s second growth driver.

Gene synthesis service costs were successfully reduced by about 10%. To enhance these services, GenScript Biotech built a fully-automated gene synthesis production line covering 5,000 square feet in the US, which is expected to increase its capacity tenfold, and save transportation costs and lead time for overseas customers.
Gene editing business increased by over 65% YoY.
Oligo business increased by over 90% YoY.
To support protein production capacity, GenScript Biotech will launch two facilities in Shanghai and Singapore.
Apart from gene synthesis services, the life science services and products business is also accelerating development across the GCT industrial chain, strengthening GenScript Biotech’s presence in this field. In the coming years, the business will deepen its investments in two GCT directions: customized products and services to meet GCT needs, including developing laboratory-level ssDNA and sgRNA, reagents and instruments; and specification upgrades made possible by industrial line automation to improve market share and profitability.

GenScript ProBio, the biologics CDMO business, generated USD 31.5 million in revenue, a 65.8% YoY increase, in the first of 2021. Gross profit yielded USD 10.0 million, representing a 112.8% YoY increase, and gross margin rose from 24.7% last year to 31.7% this year. Revenue growth was mainly driven by successful ongoing antibody CDMO projects and rapid expansion of the GCT CDMO business.

The business has advanced its capabilities in challenging molecule development, driving revenue from antibody and protein CDMO services to increase by 58.3%. Revenue from emerging GCT CDMO services skyrocketed YoY, maintaining GenScript ProBio’s leading position in the GCT CDMO industry:

In terms of plasmid services, GenScript ProBio is the only company in China equipped with a GMP certified linearized plasmid production platform. GenScript ProBio has virtually cornered the pre-clinical and clinical plasmid supply market for mRNA vaccine R&D companies in China.
On viral vectors, GenScript ProBio developed China’s first proprietary lentivirus suspension production platform, with a virus yield that is equivalent to or higher than that of the most widely used cell line on the market. The business will also soon be launching its proprietary AAV suspension production platform.
With its independent financing capabilities, GenScript ProBio is prioritizing investments in capacity upgrades and infrastructure for its both GCT CDMO business and antibody CDMO business.

The second GMP certified plasmid facility in Zhenjiang, China, is expected to be up and running within the year, which will enable GenScript ProBio to more than double its current plasmid production capacity.
A new R&D building in Nanjing will be added to further enhance GenScript ProBio’s antibody discovery and development capabilities in upstream services.
The biologics fill-and-finish line is now under construction and is expected to be operational in the second half of 2022 to better meet customer needs for commercial production.
A 12,000 L-capacity production center in Zhenjiang, China is under construction to accelerate capacity expansion in commercialization.
Legend Biotech, the cell therapy business, continued to progress in the first half of 2021 and yielded USD 33.9 million in revenue, a 46.8% YoY increase, mainly from amortization of upfront and milestone payments received from its collaboration with Johnson & Johnson. Legend’s R&D expenses rose to USD 154.5 million in the first half of 2021, mainly on cilta-cel clinical trials in the US and China.

As Genscript Biotech continues to expand its business in the GCT industry, Legend Biotech has leveraged cilta-cel to enhance its in-depth industry experience and insights, which also betters the Group’s understanding of client demands in its non-cell therapy business. Legend Biotech is expected to obtain commercialization approval for cilta-cel from the US FDA for end-line treatment before the end of this year. Legend will submit BLAs for cilta-cel in China and Japan in the second half of 2021, and strives to acquire commercialization approval in Europe and China in 2022.

The company also has several CAR-T therapies in the pipeline targeting hematologic malignancies, solid tumors and infectious diseases, along with a variety of autologous CAR-T, allogenic CAR-T and TCR-T R&D platforms. Legend Biotech is pushing forward its LB1901 program for the treatment of refractory and recurring T-cell lymphoma.

In addition, Legend Biotech has established production facilities in New Jersey (US), Belgium (Europe), and Nanjing (China), expanding its capacity for upcoming global commercialization.

Bestzyme, the industrial synthetic biology products business, generated USD 18.0 million in revenue, a 60.7% YoY increase, and USD 5.1 million in gross profit, a 18.6% YoY increase. Revenue growth was mainly driven by a series of new product launches and continued implementation of major account strategies. In the future, Bestzyme plans to deepen its reach in the F&B, home care and chemical substitution fields. By leveraging synthetic biology, the company aims to construct new functional proteins and functional small molecules to create new value for its customers.

On August 24, 2021 GT Medical Technologies, Inc. reported it is presenting clinical data in two oral presentations on the company’s breakthrough GammaTile Therapy for patients with brain tumors at the 2021 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (Press release, GT Medical Technologies, AUG 24, 2021, View Source [SID1234586857]). The presenting authors, Dr. David Brachman, co-founder and CTO at GT Medical Technologies and Dr. Mehee Choi, director of Medical Affairs at GT Medical Technologies, will discuss new data in patients with recurrent glioblastoma (GBM), and access-to-care for patients with resectable brain tumors.

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GammaTile is an implantable radiation therapy consisting of bioresorbable collagen tiles embedded with Cesium-131 sources provided by Isoray, Inc. It is the first medical device cleared for brain tumor treatment in the U.S. in the last ten years. "GammaTile Therapy improves the lives of patients with newly diagnosed malignant and recurrent brain tumors," said Matthew Likens, president and CEO of GT Medical Technologies, Inc. "Data presented at AANS highlights clinical efficacy of the therapy, but also important access-to-care and quality-of-life benefits that GammaTile provides these patients. It’s the first device of its kind, and its ability to deliver safe and effective Surgically Targeted Radiation Therapy (STaRT) for patients is groundbreaking in the neuro-oncology community."

The in-person AANS meeting was cancelled due to Covid-19. As the pandemic disrupts travel and events, it is vital to remember that cancer treatment is not elective. GammaTile is a one-and-done radiation option for patients with brain tumors that eliminates the need for daily, ongoing radiation treatments. Patients receive ongoing, therapeutic radiation from the safety of their own home, protecting them from unnecessary exposure to Covid-19, and delivering life-extending treatment. This and other access to care benefits will be featured in the abstracts presented at AANS.

Register today here and watch the following oral presentations online:

"Resection and Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent GBM," presenting author: David Brachman, MD, Radiation Oncologist, GT Medical Technologies, Inc.
"Access to specialty radiotherapy care for patients with resectable brain tumors," presenting author: Mehee Choi, MD, Radiation Oncologist, GT Medical Technologies, Inc.
In addition to the abstracts presented at the AANS Annual Scientific Meeting, GammaTile Therapy was featured in two scientific abstracts at the 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases last week. Read the following abstracts online:

"A multicenter observational study of Cs-131 seeds embedded in a collagen carrier tile for newly diagnosed and recurrent operable intracranial neoplasms –Trial in progress," presenting author: Erin Dunbar, MD, Neuro-Oncologist, Piedmont Atlanta Health, Atlanta, GA
"Intracavitary carrier-embedded Cs131 brachytherapy for recurrent brain metastases: A randomized phase II study," presenting author: Nelson Moss, MD, Neurosurgeon, Memorial Sloan Kettering Cancer Center, New York, NY

On August 24, 2021 Investigators at Nagourney Cancer Institute in collaboration with colleagues at the Federal University of Sao Paulo, Brazil, University of California, Irvine and Todd Cancer Institute reported in a paper published by Gynecologic Oncology that metabolic signatures found in the blood of gynecologic cancer patients can identify those at the highest risk of relapse (Press release, Nagourney Cancer Institute, AUG 24, 2021, View Source [SID1234586855]). The results could herald a future in which oncologists could use a blood test done at the time of diagnosis to better manage patients with advanced gynecologic malignancies.

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Platinum resistance, defined as the lack of response or evidence of clinical relapse within six months of platinum-based chemotherapy, is an important determinant of survival in gynecologic cancer.

"We used quantitative Mass Spectrometry to identify metabolic signatures that predict platinum resistance in patients receiving chemotherapy for ovarian and uterine cancers," said Dr. Robert Nagourney, Founder and Medical Director of the Nagourney Cancer Institute. "The study provides a window into human biology that offers the opportunity for better patient outcomes and more rapid and efficient drug targeting."

With the growing interest in human metabolism as an important component of cancer biology, this study in gynecologic cancer is the most recent of several of the team’s analyses in breast cancer, multiple myeloma and other cancers that confirms metabolomics’ role as one of the most promising platforms in cancer research.

In the study, 47 patients with adenocarcinoma of the ovary or uterus who were candidates for carboplatin plus paclitaxel submitted blood for quantitation of metabolites and surgical specimens for the isolation 3-dimensional organoids used to measure individual patient platinum resistance, ex vivo. Results were correlated with response, time to progression and survival.

The study identified patients with the highest risk of relapse and death with a sensitivity of 92 percent and a specificity of 86 percent.

"With such insight, we are on the cusp of more accurately determining the best course of treatment for those with gynecologic tumors," said Dr. Nagourney.