Nevro Announces Preliminary Unaudited Fourth Quarter and Full Year 2019 Revenue

On January 14, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its preliminary unaudited revenue for the fourth quarter and year ended December 31, 2019 (Press release, Nevro, JAN 14, 2020, View Source [SID1234553202]). In addition, the Company is providing its worldwide revenue guidance for the full year 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fourth Quarter 2019
Preliminary unaudited fourth quarter 2019 worldwide revenue is expected to be $114.4 million, compared to $107.9 million in the fourth quarter in the prior year period. Preliminary unaudited fourth quarter 2019 U.S. revenue is expected to be $97.9 million, compared to $91.6 million in the prior year period. Preliminary unaudited fourth quarter 2019 international revenue is expected to be $16.5 million, compared to $16.3 million in the prior year period. Fourth quarter U.S. trial procedure growth was 17% and permanent implant procedure growth was 20%.

Full Year 2019
Nevro’s preliminary unaudited full year 2019 worldwide revenue is expected to be $390.3 million, compared to $387.3 million in the prior year period. Preliminary unaudited full year U.S. revenue is expected to be $326.0 million, compared to $321.8 million in the prior year period. Preliminary unaudited full year international revenue is expected to be $64.3 million, compared to $65.5 million in the prior year period.

Worldwide Revenue Guidance for Full Year 2020
Nevro currently expects full year 2020 worldwide revenue to be in the range of $435 to $440 million. The Company plans to provide additional guidance metrics for 2020 when it reports its fourth quarter and full year 2019 results in February.

The United States Patent and Trademark Office has registered the LIDDS trademark NANOZOLID in the US

On January 14, 2020 LIDDS AB (publ) reported that the United States Patent and Trademark Office has registered the trademark NanoZolid (Press release, Lidds, JAN 14, 2020, View Source [SID1234555898]). LIDDS thereby has exclusive rights to the trademark for products and services in the USA and in the EU, where NanoZolid has been registered since 2016.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The registered Trademark NanoZolid, without any claim to particular font, size or color, has registration no. 5,830,505 and includes International Classes 5 and 42.

-This is an essential, although expected, step in establishing the concept of LIDDS proprietary drug delivery technology NanoZolid for local depots and adds to our already strong IP portfolio, confirms LIDDS CEO Monica Wallter.

Celsee and Kindstar Global Collaborate to Bring Advanced Tools for Monitoring Circulating Tumor Cells to Scientists in China

On January 14, 2020 Celsee, Inc., a leading provider of single-cell isolation technology, and Kindstar Global, the largest medical esoteric testing service group in China, reported a purchase agreement to provide scientists at the Kindstar Laboratory System in China with Celsee’s Genesis System for monitoring circulating tumor cells (CTCs) in lung, breast, and bladder cancers as well as single-cell research (Press release, Celsee, JAN 14, 2020, View Source [SID1234553186]). In addition, Kindstar will become a distributor of Celsee’s products in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For this cancer research, Kindstar scientists will use the BioINK kit, which was developed by IncellDx for CTC enumeration in therapeutic monitoring and is performed on Celsee’s Genesis System utilizing the Celselect Technology. Now, researchers will gain access to Celsee’s Genesis System, which has better capture efficiency and detection of CTCs compared to other CTC enumeration platforms.

"Kindstar Global is leading the way for oncology research and testing in China, and we are committed to implementing the most advanced tools for that work," said Dr. Shiang Huang, Founder and CEO of Kindstar. "We are truly impressed by the capabilities of Celsee’s single-cell isolation and enumeration technology and are eager to use it in our own laboratories as well as to make it available to scientists throughout China."

John Stark, Chief Executive Officer of Celsee, commented: "We are very excited to announce the partnership with Kindstar and the opportunity to bring Celsee technology to the clinical research market in China. Our team has worked closely with IncellDx to develop workflows that combine our single-cell tools with their flow cytometry classification assays and BioINK assays for CTC enumeration to assess disease progression and response to therapy."

Celsee’s technology enables high-throughput analysis of single cells with industry-leading capture rates. The Genesis System supports two slide technologies. Celselect slides enrich and enumerate CTCs with high capture efficiency and detection rates. Celsingle slides use a gentle, gravity-based method to capture and isolate thousands of individual cells while maintaining viability and structural integrity for robust downstream analysis in both genomic and proteomic applications and improved sensitivity compared to other single-cell technologies.

Caris Life Sciences Adds Premier Academic Brain Tumor Center to its Precision Oncology Alliance

On January 14, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that The Preston Robert Tisch Brain Tumor Center at Duke University Hospital has become the 32nd member of its Precision Oncology Alliance (Press release, Caris Life Sciences, JAN 14, 2020, View Source [SID1234553203]). The Alliance is a collaborative network of leading cancer centers that demonstrates a commitment to precision medicine. These centers work together toward a common goal to advance tumor profiling and establish standards of care for molecular testing in oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Preston Robert Tisch Brain Tumor Center was one of the first brain tumor research and clinical programs in the United States. Since then, it has advanced to become one of the best pediatric and adult neuro-oncology programs in the world—leading the way in comprehensive care that combines research breakthroughs, clinical trials and the newest therapies. The National Cancer Institute (NCI) has given the center the highest rating of "exceptional" for each of the last 15 years.

The mission of the Center is to provide hope and empower brain tumor patients with unparalleled care, research and education. The Center sees up to 900 new adult brain tumor patients and up to 75 new pediatric brain tumor patients per year from across the country and around the world.

"We are excited to welcome Preston Robert Tisch Brain Tumor Center into the Precision Oncology Alliance," said Brian J. Brille, Vice Chairman of Caris Life Sciences. "The Preston Robert Tisch Brain Tumor Center is globally recognized for its collaborative spirit and commitment to its patients and we expect this partnership with the Alliance members to help further progress the potential of molecular profiling."

Through the Precision Oncology Alliance – powered by Caris – The Preston Robert Tisch Brain Tumor Center will partner with other notable cancer centers and academic institutions to broaden patient access to precision cancer care, have early access to Caris’ Next Generation Profiling offerings, and establish evidence-based standards for tumor profiling and molecular testing in oncology. By leveraging the comprehensive genomic and proteomic tumor profiling services available through the Caris Molecular Intelligence platform, oncologists from the Center will be able to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. Additionally, the Center’s researchers will partner with other Alliance members to contribute to and publish data and advance collaborative clinical trials.

"We are well known for pioneering cancer research that results in optimal, individualized treatment," said David Ashley, Ph.D., a Neuro-oncologist and Pediatric Neuro-oncologist at Duke Cancer Center. "We look forward to collaborating with Caris Life Sciences and the members of the Precision Oncology Alliance to fuel the next great discoveries in precision medicine."

The Precision Oncology Alliance comprises 32 academic, hospital and community-based cancer institutions, including ten NCI-designated Comprehensive Cancer Centers. The Alliance now includes over 1,350 physicians, spanning more than 400 locations, who provide services for over 280,000 people with cancer each year. Precision Oncology Alliance members also have access to Caris Pharmatech’s oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

Lucence Presents Data Demonstrating Potential of AmpliMARK™-Powered Sequencing to Detect Genomic Alterations at High Sensitivity in Blood Cancers

On January 14, 2020 Singapore-based precision oncology startup Lucence, reported on the heels of its series A funding, is sharing early data highlighting the capabilities of its liquid biopsy technology to detect somatic variants in patients with blood cancers, with excellent matching between bone marrow and blood (Press release, Lucence, JAN 14, 2020, View Source [SID1234553187]). Lucence’s amplicon-based sequencing technology, known as AmpliMARK, can provide high sensitivity mutation detection in blood for multiple solid tumor types. This new study data demonstrates the performance of AmpliMARK in hematological malignancies, and suggests that it can provide high resolution, target-rich insights for clinicians and patients to better, and less invasively, manage these diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Liquid biopsy aims to use blood as a platform for cancer screening, diagnosis, treatment, and monitoring. In the case of hematological malignancies like leukemia, current bone marrow-based tests for detecting and monitoring disease progression offer limited sensitivity and are highly invasive. Lucence’s findings suggest that a blood-based liquid biopsy test could be a compelling, highly sensitive clinical alternative to these tests.

Lucence’s poster highlighting their recent study results, Ultrasensitive Detection of Diverse Genomic Alterations in Hematological Malignancies using a Targeted Amplicon-based Sequencing Approach, will be presented Tuesday, January 14th at 4:15 pm Eastern Time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Liquid Biopsies meeting in Miami. Based on a study of 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma, the poster reports high sensitivity of AmpliMARK in detecting genomic alterations in blood and bone marrow samples. The study results show that AmpliMARK detects mutations at a sensitivity down to 0.1% variant allelic frequencies (VAF) and fusion genes like BCR-ABL1 down to 1% VAF. The results also show excellent concordance between bone marrow and blood, suggesting blood could be a viable medium of detection when marrow is challenging to obtain.

AmpliMARK uses a unique molecular bar-code and error correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational breakthrough technology in Lucence’s offering of blood-based tests for both profiling hematological and solid tumors.

Dr. Zi Yi Lim, senior consultant haematologist at the Centre for Clinical Haematology and study co-author, said, "Molecular diagnostics are an essential part of the workup and an important follow up tool in patients with blood cancers. Bone marrow assessments remain the gold standard investigation to evaluate the genomic disease profile of these patients. However, bone marrow assessments are costly, invasive and uncomfortable for the patient. The finding that Lucence’s technology can detect even low-level mutations in peripheral blood of patients with a high level of concordance to bone marrow is an exciting development. This could facilitate more convenient, cost-effective and regular disease assessments of such patients with a blood test."

Lucence is currently preparing to open their Silicon Valley laboratory to make their liquid biopsy tests more widely available to US clinicians and patients. While the Company’s initial focus in the US will be in profiling late-stage lung cancer patients for treatment selection, the data presented at the AACR (Free AACR Whitepaper) conference provides early validation of the core technology of Lucence’s liquid biopsy tests. Lucence announced their $20 million Series A led by IHH Healthcare, one of the world’s largest integrated private healthcare groups, in November 2019, and their executive team will be attending the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco.