[Translation] A parallel double-blind randomized positive controlled study to evaluate the efficacy and safety of BDDE-cross-linked sodium hyaluronate injection and sodium hyaluronate injection in patients with knee osteoarthritis

比较BDDE-交联玻璃酸钠注射液（LBSA0103）单次给药和玻璃酸钠注射液（Synvisc inj.）按照1周时间间隔3次给药的疗效和安全性。

[Translation]

To compare the efficacy and safety of a single dose of BDDE-cross-linked sodium hyaluronate injection (LBSA0103) and three doses of sodium hyaluronate injection (Synvisc inj.) at 1-week intervals.

Start Date28 Aug 2019

Sponsor / Collaborator

LG Chem Ltd.

[+1]

RBR-66tppc / Active, not recruitingPhase 2IIT

Hilano G-F 20 versus triamcinolone in the treatment of primary shoulder osteoarthrosis. Randomized controlled clinical trial.

Start Date02 Jul 2018

Sponsor / Collaborator

Universidade Federal De Sao Paulo

[+1]

CTR20170202 / CompletedPhase 3

评价膝骨关节炎患者接受Hylan G-F 20（Synvisc-One）单次给药的有效性和安全性的平行双盲随机、安慰剂对照研究

[Translation] A parallel double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of a single dose of Hylan G-F 20 (Synvisc-One) in patients with knee osteoarthritis

主要目的: 根据西安大略和麦克马斯特大学骨关节炎指数（WOMAC）数字评定量表（NRS）3.1 A1评分，评价在中国症状性膝骨关节炎患者中，单次关节内（IA）注射6 mL Hylan G-F 20在26周过程中的有效性次要目的: 7天平均WOMAC A1疼痛亚评分，评价有效性与IA注射安慰剂相比，根据WOMAC A 、PTGA及COGA，，评价单次IA注射6 mL Hylan G-F 20有效性和应答率和安全性

[Translation]

Primary Objective: To evaluate the efficacy of a single intra-articular (IA) injection of 6 mL Hylan G-F 20 over 26 weeks in Chinese patients with symptomatic knee OA based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS) 3.1 A1 score Secondary Objectives: To evaluate the efficacy based on the 7-day mean WOMAC A1 pain subscore To evaluate the efficacy and responder rate and safety of a single IA injection of 6 mL Hylan G-F 20 compared with IA injection of placebo based on WOMAC A, PTGA, and COGA

Start Date21 Aug 2017

Sponsor / Collaborator

PPD Laboratories (Beijing) Co., Ltd

[+1]

100 Clinical Results associated with Cross-linked Sodium Hyaluronate

100 Translational Medicine associated with Cross-linked Sodium Hyaluronate

100 Patents (Medical) associated with Cross-linked Sodium Hyaluronate

296

Literatures (Medical) associated with Cross-linked Sodium Hyaluronate

01 Aug 2024·Acta ophthalmologica

Application frequency – key indicator for the efficiency of severe dry eye disease treatment – evidence for the importance of molecular weight of hyaluronan in lubricating agents

Article

Author: Horwath‐Winter, Jutta ; Boldin, Ingrid ; Berisha, Bujar ; van Setten, Gysbert‐Botho ; Schwantzer, Gerold ; Matijak‐Kronschachner, Bernadette ; Aminfar, Haleh ; Müller‐Lierheim, Wolfgang G. K. ; Medic, Nika

Abstract:

Purpose:

Lubricant eye drops are the main therapeutic resource for dry eye disease (DED), with each drop representing the equivalent of ocular surface disease treatment. Thus, any reduction in the frequency of eye drop application reflects a degree of therapeutic success. Considering also the socioeconomic burden of DED, we investigated eye drop application frequency (DF) as a parameter to potentially track the success of therapy in severe DED. Hyaluronan (HA)‐containing eye drops have become the first choice for tear substitution in many countries, and recent data indicate that the average molecular weight (Mw) of HA determines the therapeutic efficacy of such eye drops. This post‐hoc subgroup analysis of a previously published multicentre prospective randomized open‐label study, HYLAN M, is set out to compare the effects of very high Mw HA (hylan A) eye drops to comparator eye drops, containing lower Mw HA (control).

Methods:

Patients with severe DED (n = 47), recruited as part of the larger HYLAN M prospective, multicentre, open‐label study, were randomized into two groups: hylan A and control group. In the hylan A group, 24 patients replaced their HA‐containing eye drops with eye drops containing 0.15% hylan A, whereas the 23 control patients continued to use comparator HA eye drops. The DF was recorded daily by all participants over 8 weeks, and other subjective and objective parameters of DED were assessed at the time of inclusion (baseline), as well as at week 4 and 8.

Results:

There was a significant decrease in DF in the hylan A users between the baseline and week 4 (p = 0.004), remaining stable until week 8. Indeed, in contrast to the baseline, the hylan A group had a significantly lower DF than the control group at weeks 4 (p = 0.018) and 8 (p = 0.008). Likewise, the ocular surface disease index (OSDI) improved significantly between the time of inclusion and week 4 (p < 0.001) in hylan A users, remaining stable until week 8. The OSDI was similar in both groups at the baseline but it was significantly lower in the hylan A group than in the control group at week 4 (p = 0.002), remaining lower at week 8. Such a decrease in the DF and OSDI was not witnessed in the control group at any time point. The objective parameters assessed did not differ significantly within or between the two groups.

Conclusion:

When treating severe DED, the DF can be significantly reduced by using very high Mw HA (3 MDa) lubricant eye drops, which better alleviate DED symptoms and decrease the OSDI scores. These drops not only provide an attractive and comfortable alternative for patients with severe DED but also offer the possibility of reducing the disease's socioeconomic burden, both for affected individuals and society as a whole.

01 Jan 2024·Advances in therapy

Health Economic Assessments of Hyaluronic Acid Treatments for Knee Osteoarthritis: A Systematic Review

Review

Author: Phillips, Mark ; Niazi, Faizan ; Guo, Amy ; Guo, Kaiwen ; Bhandari, Mohit ; Waterman, Brian ; Ranawat, Anil

INTRODUCTION:

Hyaluronic acid (HA) use to treat knee osteoarthritis (OA) has been extensively investigated in the literature. There are also multiple economic assessments comparing intra-articular HAs with oral anti-inflammatory medicines and other conservative measures (NSAIDs), as well as different types and formulations of HA. Owing to the broad landscape of evidence across this area, it is important to further understand the empirical data comparing HA products, as well as the health economic implications that exist between commercially available HAs. This systematic review aims to identify and summarize the available evidence comparing commercially available HA products in the USA, as well as the health economic evidence and socioeconomic outcomes associated with HA use for knee OA.

METHODS:

A systematic literature review within the OVID Medline, Embase, HealthStar, and Cochrane EBM HTA databases was conducted. Articles were screened for eligibility, and a qualitative summary of the findings was provided based on specific themes: (1) trials comparing the safety and/or efficacy of two or more HA products in knee OA, (2) economic/cost analyses of HA use in knee OA, and (3) studies investigating healthcare resource utilization in patients treated with HA for knee OA.

RESULTS:

The search strategy identified 398 studies, 27 of which were deemed eligible: 21 health economic analyses with US relevance and six head-to-head trials of HA products available in the USA, cumulatively assessing 5,782,156 patients with knee OA. The evidence demonstrates a clear distinction between high and low molecular weight HAs, as both efficacy and cost analyses provided favorable results for the high molecular weight options. In all but one cost analysis, HA use was a cost-effective option when compared to routine nonoperative care, captured in administrative databases, which typically included NSAID use and/or corticosteroids. HA saw benefits in delaying the need for total knee arthroplasty (TKA), decreasing the use of rescue medication, and limiting the need for additional corticosteroid injection. The included evidence highlights that the treatment's cost-effectiveness is improved when HA is utilized in earlier stages of the disease, as opposed to when HA is reserved for late stages of knee OA. Additionally, among HAs, Bio-HA and Hylan G-F 20 evidence made up the majority of available literature with beneficial efficacy and cost outcomes. Head-to-head evidence between them indicated similar pain outcomes; however, Bio-HA required less rescue with acetaminophen and had fewer joint effusions in this comparison.

CONCLUSIONS:

The available efficacy and safety data as well as health economic analyses on the use of HA for knee OA management suggest that there are economic benefits of this treatment option. From a healthcare system perspective, the body of HA literature summarizes favorable costs profile, decreased opioid and corticosteroid use as rescue medication, and a delay to the need for TKA in patients who have HA included in their treatment regimen.

01 Oct 2023·Rheumatology and therapy

Is the Rate of Responders to Hyaluronic Acid Injection for Patients with Knee Osteoarthritis Stable Over Time? Post hoc Analyses of a 6-Month Follow-Up Study.

Article

Author: Vidovic, Eduard ; Bruyere, Olivier ; Honvo, Germain ; Cortet, Bernard

INTRODUCTION:

Recently, a study showing the non-inferiority of a single injection of sodium hyaluronate plus sorbitol (Synolis VA^®) compared to hylan G-F20 (Synvisc-One^®) over a 24-week period in patients with knee osteoarthritis was published. The objective of the present study is to assess if a short-term response to a single injection of sodium hyaluronate plus sorbitol can be maintained over a 6 month-period and if the maintenance of the response to treatment is dependent on the functional status at baseline.

METHODS:

Responders to treatment at days 28, 84, and 168 were evaluated according to the responder criteria proposed by the OMERACT-OARSI. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess functional status at baseline. All analyses were adjusted for age, gender, BMI, and baseline WOMAC total score using data from the intention-to-treat (ITT) population.

RESULTS:

Out of the 96 patients included in the study who were receiving Synolis VA^®, 59.38% were responders at day 28 according to the OMERACT/OARSI responder criteria, 59.78% at day 84, and 64.52% at day 168. Among the responders at D28, the probability of being responder at D84 and D168 was significantly higher than among non-responders, with corresponding odds ratio (95% CI) of 2.85 (1.07-7.59) and 7.28 (2.53-20.93), respectively. Patients with a poorer physical function at baseline were more likely to respond to the treatment at all time points, compared to those with a better physical function (OR 3.74 [1.37-10.21]).

CONCLUSIONS:

An early response of a single injection of sodium hyaluronate plus sorbitol is predictive of long-term response, up to 24 weeks. Patients with a poorer physical function may best benefit from the treatment.

News (Medical) associated with Cross-linked Sodium Hyaluronate

20 Mar 2024

·www.biospace.com

Breakthrough Results of NIH-Sponsored Study of Syn-One Test® as a Skin-Based Diagnostic Tool for Parkinson’s Disease and Related Disorders Published in the Journal of the American Medical Association

- Study demonstrates alpha-synuclein biomarker can be detected in 93-100% of patients with clinically defined pathologies using simple skin biopsy procedure - Syn-One Test addresses key unmet needs by supporting accurate diagnoses for patients and serving as a reliable biomarker for clinical trials SCOTTSDALE, Ariz.--(BUSINESS WIRE)-- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced a pivotal peer-reviewed publication entitled, “Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients with Synucleinopathies”1 in the Journal of the American Medical Association (JAMA). The publication by Gibbons et al. (2024) was a cross-sectional study of patients in academic and community-based neurology practices in people with a clinical diagnosis of Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), collectively known as synucleinopathies, and healthy subjects to evaluate the positivity rate of phosphorylated alpha-synuclein (P-SYN) detection through a skin biopsy test. Supported by the National Institutes of Health (NIH), this blinded, 30-site, 428-patient study has the potential to unlock a new era in diagnostic testing and address urgent unmet needs by reducing common misdiagnoses while enhancing clinical drug development efforts. The primary goal of this study was to define the positivity rate of skin biopsies to detect P-SYN deposition in clinically confirmed cases of PD, MSA, DLB, and PAF. The proportion of patients with P-SYN was 92.7% in those with PD, 98.2% in those with MSA, 96.0% in those with DLB, and 100% in those with PAF. The proportion of healthy subjects with P-SYN was only 3.3%. The results from this study demonstrate the opportunity to use alpha-synuclein detection in cutaneous nerves as a reliable and convenient diagnostic tool for clinical practice and as a quantifiable biomarker to evaluate disease severity and progression. “This study validates the role of skin biopsy detection of phosphorylated alpha-synuclein as an important diagnostic tool for physicians and patients,” said lead author Christopher Gibbons, MD, Senior Scientific Advisor and Co-Founder of CND Life Sciences and Professor of Neurology at Harvard Medical School. “Accessibility to accurate testing modalities that pinpoint the pathology of these diseases has been a real challenge for both clinical practice and clinical trials, so we are quite pleased to see the strong positivity and specificity results of using skin as a reliable diagnostic method.” Scientific literature has suggested that synucleinopathies, including PD, may be misdiagnosed over 30% of the time, particularly earlier in the disease course. Furthermore, in a recent study of Medicare patients diagnosed with PD (published in npj Parkinson’s Disease in 2023), barriers to more specialized neurology care have created significant health disparities for patients. Future disease-modifying therapies will require convenient, accurate, and precise diagnostic tools to reach the right patients at the right time across a wide array of communities. “Detecting phosphorylated alpha-synuclein through cutaneous nerves is a more convenient pathway than other tests requiring spinal fluid or nuclear medicine imaging,” said Todd Levine, MD, Chief Medical Officer of CND Life Sciences and principal investigator on the study. “The Syn-One Test has been ordered by over 1,200 neurologists in 46 states to aid the diagnosis of 20,000 patients in the last few years. By providing objective, visual proof of the known pathological marker of Parkinson’s disease, dementia with Lewy bodies, and other synuclein disorders, the Syn-One Test is truly helping clinicians increase diagnostic confidence and provide better care to patients.” CND’s research team and collaborators continue to advance the science that underlies the Syn-One Test through a range of exploratory programs and clinical studies focused on early disease detection, biosignatures of specific disease subtypes, and correlations with other neurological biomarkers. “We believe this is a crucial decade of innovation for the neurodegeneration field, one that will result in major progress in precision diagnostics, new treatments, and more promising futures for patients and families,” noted Roy Freeman, MD, Senior Scientific Advisor and Co-Founder of CND Life Sciences and Professor of Neurology at Harvard Medical School. “The publication of this important NIH-sponsored study is one big step forward with many more milestones to come.” About CND Life Sciences CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND launched the Syn-One Test® in 2019 as the world's first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. This laboratory-developed test analyzes three small skin biopsies collected from the patient in a physician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. The Syn-One Test is supported by technology and expertise licensed from Beth Israel Deaconess Medical Center in Boston through the Center for Autonomic and Peripheral Nerve Disorders and the research laboratory of Dr. Roy Freeman and Dr. Christopher Gibbons. The Company has research collaborations with multiple biopharmaceutical companies. It has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test, including assessing the test’s ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn. Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 1Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. Published online March 20, 2024. doi:10.1001/jama.2024.0792

Clinical ResultClinical Study

25 Jan 2024

·www.globenewswire.com

BioSenic presents new Phase 3 data on JTA-004 to treat severe osteoarthritis pain at the 2024 OARSI World Congress

PRESS RELEASE BioSenic presents new Phase 3 data on JTA-004 to treat severe osteoarthritis pain at the 2024 OARSI World Congress Using a recently published approach to stratify patients with knee osteoarthritis, an external post hoc analysis of Phase 3 data showed JTA-004 is safe and efficient for treating pain symptoms in the most severely affected patients. Mont-Saint-Guibert, Belgium, January 25 2024, 7.00 am CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, will for the first time share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. The post hoc analysis of a Phase 3 study found that a single injection of JTA-004 was safe and efficacious for patients with a newly characterized severe inflammatory subtype of knee osteoarthritis (OA). The data will be presented by Yves Henrotin, Ph.D, a professor at University of Liège in Belgium (musculoSKeletal Innovative research Lab, mSKIL), Center for Interdisciplinary Research on Medicine, CIRM), as well as Founder and the Chairman of the Board of Artialis, which performed the analysis. JTA-004 is an innovative intra-articular viscosupplement treatment for knee OA, composed of hyaluronic acid, plasmatic proteins, and clonidine. The post-hoc analysis addresses different subpopulations of OA patients in the data of a Phase 3 trial (KOA-2) completed in 2019. The trial was intended to demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity compared to saline solution or Synvisc-One®, three months after injection, in subjects suffering from symptomatic knee OA. The initial results in a broad pool including patients with several subtypes were inconclusive. However, BioSenic was inspired to reevaluate the previous data following the publication of a study1 that identified biomarkers to stratify OA phenotypes, including a disease subtype characterized by systemic inflammation and the most severe symptoms. The conclusion of the post hoc analysis is that JTA-004 is safe and effective for successfully treating symptoms in this inflammatory-driven subgroup. François Rieger, Ph.D, President of the Board and CEO of the BioSenic Group, said: “We thank Prof. Henrotin, a renowned specialist, and his team of biostatisticians for this collaboration. This new, detailed analysis demonstrates the positive therapeutic effect of JTA-004 in severe OA, and it will enable a more specific approach to the unsolved problem of efficient pharmacological treatment of osteoarthritis pain.” “OARSI is dedicated solely to advancing OA research. It brings together KOLs and renowned researchers from around the world to facilitate the translation of knowledge about OA, a debilitating disease that affects about 528 million people worldwide and rising sharply. With more than 30 years of experience serving the OA community, OARSI provides the necessary framework, expert resources, and support for its international members to address the challenges of OA so that the knowledge gained can ultimately be used to improve patient care and outcomes,” said Carole Nicco, Ph.D, BioSenic Chief Scientific Officer and Chief Operating Officer. “We are pleased to share our findings at the Congress and hope that these data will support the further evaluation of our viscosupplement, which has all the characteristics to treat severe inflammatory OA and address an unmet medical need.” BioSenic recently filed an additional patent application to support further development of JTA-004 for severe OA. “A single intra-articular injection of JTA-004 is safe and efficient for treating symptoms in the most severely affected knee osteoarthritis (OA) patients – a multicenter, randomized, double-blind, placebo-and active-treatment controlled phase 3 clinical trial” will be presented at OARSI World Congress 2024, held April 18-21 in Vienna, Austria. 1 Angelini F, et al. Ann Rheum Dis Feb 2022 About BioSenic BioSenic is a biotech company specializing in the clinical development of autoimmune disease therapies. Following a reverse merger in October 2022, BioSenic combined its strategic positioning, key strengths and strong IP to develop products along two tracks, separately and in combination. The first platform leverages immunomodulatory properties of arsenic trioxide (ATO) for an entirely new arsenal of formulations, including oral delivery (OATO), for anti-inflammatory and anti-autoimmune indications such as chronic graft-versus-host disease (cGvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). In parallel, BioSenic develops innovative products through a second platform that includes cell therapies and strong IP protection for tissue repair technologies. BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com. About BioSenic's technology platforms The ATO platform has immunomodulatory properties with fundamental effects on the activated cells of the immune system. One direct application is its use in autoimmunity to treat in its chronic, established stage. Chronic GvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT), a curative treatment for patients with serious blood diseases, including cancers. BioSenic’s intravenous ATO formulation, Arscimed®, has orphan drug designation status by FDA and EMA, and it has shown good safety and significant clinical efficacy for skin, mucosae, and the gastrointestinal tract in an early Phase 2a study. The company is planning a confirmatory international Phase 3 study with its oral ATO (OATO) formulation. OATO will also target moderate-to-severe forms of SLE. BioSenic is also developing a new IP-protected OATO formulation for the treatment of SSc, a serious chronic disease that affects skin, lungs or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models support the launch of a Phase 2 clinical trial. ALLOB is an allogeneic cell therapy platform made of differentiated, bone marrow-sourced mesenchymal stromal cells (MSCs), which can be stored at the point-of-use in hospitals. ALLOB represents a unique and proprietary approach to organ repair, and specifically to bone regeneration, by turning undifferentiated MSCs from healthy donors into bone-forming cells at the site of injury. BioSenic is studying the results of a Phase 2 trial to optimise the efficacy of ALLOB by determining the best timing for therapeutic intervention and seeking partners to continue the development of the promising underlying therapy strategies. The company is also exploring partnerships at all levels for its JTA-004 viscosupplement for a severe inflammatory subtype of osteoarthritis, following a positive post hoc analysis of Phase 3 data demonstrating safety and efficacy in support of this licensing. For further information, please contact: BioSenic SAFrançois Rieger, PhD, CEOTel: +33 (0)671 73 31 59investorrelations@biosenic.com International Media Enquiries:IB CommunicationsMichelle BoxallTel: +44 (0)20 8943 4685michelle@ibcomms.agency For French Investor Enquiries:Seitosei ● ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11 22 ghislaine.gasparetto@seitosei-actifin.com Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the company or, as appropriate, the company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Phase 3Phase 2Cell TherapyClinical ResultOrphan Drug

06 Apr 2023

·www.prnewswire.com

CND Life Sciences Closes Series Seed 3 Round, Reaches $12.5 Million in Total Equity Raised

CND raised an additional $1 million in venture financing from Top Corner Capital SCOTTSDALE, Ariz., April 6, 2023 /PRNewswire/ -- CND Life Sciences, a medical technology company pioneering the development of reliable skin-based tests to help clinicians diagnose neurodegenerative disorders like Parkinson's disease and dementia with Lewy bodies, today announced the closing of a $4.5 million Series Seed 3 equity financing round. This follow-on round brings the Company's total Seed financing to $12.5 million to continue accelerating the commercialization of the Syn-One Test®, the first commercially available test that can identify abnormal alpha-synuclein aggregation through a simple skin biopsy. Several existing investors as well as new investors participated in the round, and Top Corner Capital provided a concurrent financing vehicle, demonstrating enthusiasm for CND's strong progress and future. "CND's Syn-One Test represents a breakthrough in providing clinicians and patients with definitive, pathological proof of disease that can allow for more optimal treatment and shared decision-making," said Patrick Lee, Managing Partner of Top Corner Capital. "Top Corner is constantly looking for promising and disruptive technology investments that will positively impact the lives of people around the world. We look forward to supporting CND's novel and innovative approach to neurological disease testing and its continued growth." Since 2021, CND has experienced rapid growth, taking the Company from fewer than 10 employees to over 60 in 2023 and expanding its talent pool across the country. Seed financing has also accelerated the commercialization of Syn-One with nearly 700 neurologist clinician customers in over 40 states and collaborations with biopharmaceutical companies. The ongoing financial support of investors has also contributed to the expansion of the Company's headquarters, with the recent opening of its global headquarters and labs in Scottsdale, AZ in March 2023. "Having consistently engaged investors through each of our financings has been an essential component to our growth as we bring CND's important diagnostic technology to market," said Rick Morello, CEO of CND Life Sciences. "Proceeds from the Seed 3 round, including the helpful add-on of financing from Top Corner Capital, will facilitate our continued development and expansion while positioning us for wide adoption by neurologists and biopharmaceutical companies alike." CND develops and commercializes skin-based tests to help clinicians across the country accurately diagnose and treat neurologic disorders such as Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, and peripheral neuropathies. Peer-reviewed studies indicate that many of these disorders have high rates of misdiagnosis particularly early in the disease process, often leading to sub-optimal treatment for patients and significant frustration for family caregivers. The Syn-One Test is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston. About CND Life Sciences and the Syn-One Test CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified laboratory in Scottsdale, Arizona, CND launched the Syn-One Test in 2019 as the world's first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. The test, which analyzes small skin biopsies collected from the patient in a physician's office, aids in the diagnosis of a synucleinopathy including Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder. With data demonstrating high sensitivity and specificity, the Syn-One Test leverages a decade of published science from leading academic institutions in multiple countries. CND has research collaborations with multiple biopharmaceutical companies and has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test. For more information visit . Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. SOURCE CND Life Sciences

100 Deals associated with Cross-linked Sodium Hyaluronate

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Osteoarthritis, Knee	CN	Genzyme Corp.	28 Jul 2016
Arthropathy of knee joint	CA	Genzyme Corp.	11 Nov 1992

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Phase 3	US	Genzyme Corp.	01 Aug 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Cartilage	Not Applicable	Osteoarthritis, Knee	368	Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH])	vdfuskhxvw(eepiwkcsyw) = yricyayoop hpvzxjrcuu (jvkhsnhmfi )	Positive	01 Jul 2018
ACR2017	Not Applicable	Osteoarthritis, Knee	352	Hylan G-F 20 6ml	gxdypblkei(wxswcoiluc) = vkqckuvgec edqqalhfsa (pzjtpgrvrx )	Positive	07 Nov 2017
NCT00398866 (CTgov)	Phase 3	Osteoarthritis	200	Bupivicaine (Bupivicaine)	qeztopwvbf(zjzcruyuun) = zbbmdxrfjl ggbokrpgjs (ojdoshuadd, vuimfhyooa - qjzqhygplo) View more	-	07 Jul 2017
NCT00398866 (CTgov)	Phase 3	Osteoarthritis	200	Triamcinolone (Triamcinolone)	qeztopwvbf(zjzcruyuun) = xqkonrmuum ggbokrpgjs (ojdoshuadd, eldhmkpowi - zonjyyxkoj) View more	-	07 Jul 2017
NCT01586338 (CTgov)	Phase 4	Osteoarthritis, Knee	237	Hylan G-F 20	rcqyxxgool(qsebblmedy) = dzatsglwbv dyqfsgpvko (tmvjpllzme, xpdraugupx - woudmalchp) View more	-	24 Feb 2016
NCT02389452 (OASIS, CTgov)	Phase 4	Osteoarthritis, Knee	394	Synvisc-One	mjgyilqtgw(ddmgakzuer) = cossngizfa nulbeodehd (srrdzlpisf, nqdswwirjw - yjgkegcxrj) View more	-	21 May 2015
EULAR2012	Not Applicable	Osteoarthritis, Knee	451	6 ml hylan G-F 20	lqfsefufsm(fxljpchfgc) = Treatment-related adverse events (AEs) were observed in 1.93% of patients. None of these AEs was serious. tregduewjl (xpfigygjqc )	Positive	06 Jun 2012
ARVO2012	Not Applicable	Blister	-	Crosslinked Sodium Hyaluronate	rtvywvncqu(amtsramzbe) = dokohgffok ecnqalndie (qbxofxfrrh ) View more	-	01 Mar 2012
ARVO2012	Not Applicable	Blister	-	Crosslinked Sodium Hyaluronate	rtvywvncqu(amtsramzbe) = nepktjwdjr ecnqalndie (qbxofxfrrh ) View more	-	01 Mar 2012
EULAR2011	Not Applicable	Osteoarthritis, Knee	412	Single dose of 6 mL hylan G-F 20	jlusueiolm(pxshlbfqke) = ewunmyigke mufcpvibll (ufkfjnkkkr )	Positive	25 May 2011
EULAR2011	Not Applicable	Osteoarthritis, Knee	412	3 x 2 mL hylan G-F 20	jlusueiolm(pxshlbfqke) = kmlzrgjune mufcpvibll (ufkfjnkkkr )	Positive	25 May 2011
BIOVISCO STUDY (EULAR2010)	Not Applicable	Osteoarthritis, Knee S-C2C \| S-Cartilage oligomeric protein \| S-HA ... View more	51	Hylan GF-20	pnbejeraet(vbjkwjrvve) = wxoepsytzu cclvidyyyu (mzwwmgjzbt ) View more	-	16 Jun 2010
BIOVISCO STUDY (EULAR2010)	Not Applicable		51	Placebo	pnbejeraet(vbjkwjrvve) = zktuingfch cclvidyyyu (mzwwmgjzbt )	-	16 Jun 2010
EULAR2009	Not Applicable	Osteoarthritis, Knee	171	Hylan G-F 20 (second treatment cycle)	msapzzcsdi(hdwoiknouv) = There were no statistically significant differences in the incidence of AE's between the group receiving the repeat treatment cycle and the parallel group (n=412) receiving a first treatment cycle xkzpmstyuu (daxntvozzb ) View more	Positive	10 Jun 2009

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