Delving into the Latest Updates on Fibrin Sealant (Spinal Restoration) with Synapse

Overview

Basic Info

Drug Type

Blood components

Synonyms

BIOSTAT BIOLOGX

Target

fibrin

Mechanism

fibrin modulators(Fibrin modulators)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Intervertebral Disc DegenerationLow Back Pain

Originator Organization

Spinal Restoration, Inc.

Active Organization-

Inactive Organization

Spinal Restoration, Inc.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index.

RESULTS:

Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)).

CONCLUSION:

The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).

01 Oct 2023·Surgical endoscopy

Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial.

Article

Author: Birnie, E ; Biter, L U ; 't Hart, J W H ; Apers, J A ; Wijnand, J M A ; Huisbrink, J ; Verbrugge, S J C ; Dunkelgrun, M ; Noordman, B J

INTRODUCTION:

In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG).

METHODS:

In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality.

RESULTS:

In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien-Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported.

CONCLUSION:

This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.

2

News (Medical) associated with Fibrin Sealant (Spinal Restoration)

14 Feb 2024

·firstwordpharma.com

Grifols eyes US, EU filings for fibrinogen replacement therapy

Grifols announced data from a Phase III study showing that its blood-clotting treatment was as effective as standard therapy at managing severe blood loss in patients during surgery. The company plans to submit its fibrinogen concentrate, called BT524, for approval in both the US and Europe in the fourth quarter.Acquired fibrinogen deficiency (AFD) usually occurs during surgical procedures when there is an insufficient amount of the glycoprotein complex fibrinogen to stop bleeding. In the AdFIrst study, patients who had high blood loss during planned spinal or abdominal surgery were randomised to treatment with BT524 or with standard treatment using cryoprecipitate or fresh frozen plasma.However, the drawback with standard treatment is that plasma also contains other proteins and elements that aren't necessary, so large volumes are needed to ensure enough fibrinogen. By contrast, Grifols said its concentrate allows "patients on the operating table [to] immediately receive only what's essential to curtail haemorrhaging."The AdFIrst trial met its primary endpoint, demonstrating that BT524 was non-inferior to standard care at reducing intraoperative blood loss, with patients given the fibrinogen concentrate experiencing 291mL less blood loss versus the comparator group. Detailed results will be presented later this year.If the FDA signs off on BT524, Grifols noted that it would be the first fibrinogen concentrate approved for an AFD indication in the US. Grifols introduced a fibrinogen-based fibrin sealant five years ago.Meanwhile, Grifols recently hired new CEO Nacho Abia and said two founding family members would leave their executive posts at the company, following a damaging short seller report that questioned the Spanish drugmaker's debt ratio. Grifols has pledged to take legal action in an effort to recoup losses caused by the Gotham City Research report, which led to the company's shares plunging as much as 43% when it was released last month.

Clinical ResultPhase 3

28 Nov 2023

·www.prnewswire.com

Pramand Launches CraniSeal™ Dural Sealant to Give Surgeons a New Option for Dural Repair

BEDFORD, Mass., Nov. 28, 2023 /PRNewswire/ -- Pramand LLC announced today the US commercial launch of the CraniSeal™ Dural Sealant System. CraniSeal is indicated for use in patients ≥ 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.1 Continue Reading Assembled CraniSeal Dural Sealant CraniSeal Dural Sealant is an absorbable polyethylene glycol (PEG) hydrogel that is applied with an applicator over sutures. This sealant prevents cerebrospinal fluid from leaking out of a cranial surgery incision site. The underlying technology has been used for two decades in a variety of medical applications.1 Each year, approximately 160,000 cranial procedures are conducted in the US for reasons such as tumor resection, traumatic injury, and cerebrovascular disease. The volume of these procedures is growing by 3 – 5% annually. Cerebrospinal fluid leaks are one common complication of cranial surgery and can result in a longer hospital stay (+6 days) and higher medical costs (+$50,000).2 Amar Sawhney, PhD, Pramand's CEO, remarked, "We are excited to offer neurosurgeons and hospitals a choice for cranial dural sealing with CraniSeal which uses proven, highly effective technology with a long record of safety and efficacy." Dr. Sawhney previously invented DuraSeal® Dural Sealant, which has become the market-leading dural sealant globally. The Pramand team achieved approval for CraniSeal, a Class 3 device that required Pre-Market Approval (PMA), in just 3.5 years. A typical Class 3 device takes 7 years to achieve approval through the PMA process.3 For more information about CraniSeal, please visit . About Pramand LLC: Founded in 2020, Pramand develops implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. Pramand's team has launched over ten medical device companies based on hydrogel technology, and these companies have generated over $4B in value and exits and have helped over 5 million patients worldwide achieve better outcomes. For more information about Pramand, please visit . 1. PRA-MKT-0004, data on file. 2. Varshneya, K., Rodrigues, A. J., Medress, Z. A., Stienen, M. N., Grant, G. A., Ratliff, J. K., & Veeravagu, A. (2019). Risks, costs, and outcomes of cerebrospinal fluid leaks after pediatric skull fractures: a MarketScan analysis between 2007 and 2015, Neurosurgical Focus FOC, 47(5), E10. 3. A deep dive into the medical device development process. Within3. September 30, 2022. Accessed November 27, 2023. . PRA-MKT-0005, Rev A SOURCE Pramand

Drug Approval

100 Deals associated with Fibrin Sealant (Spinal Restoration)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Intervertebral Disc Degeneration	Phase 3	US	Spinal Restoration, Inc.	11 Nov 2009
Low Back Pain	Phase 3	US	Spinal Restoration, Inc.	11 Nov 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01011816 (CTgov)	Phase 3	Intervertebral Disc Degeneration \| Low Back Pain	220	BIOSTAT BIOLOGX (BIOSTAT BIOLOGX)	azrwuymzcg(mgailzjrii) = srqgabxqbs kuovhnagzl (hatpmgtoah, yuqqvixpzv - plmybjmtjq) View more	-	05 May 2014
				Saline (Saline)	azrwuymzcg(mgailzjrii) = zqsmysliya kuovhnagzl (hatpmgtoah, hwnavghwgq - pjyphwwfus) View more
NCT01649505 (CTgov)	Not Applicable	Postoperative Complications \| Seroma \| Breast Cancer	2	breast reconstruction+fibrin sealant (Beriplast P, TISSEEL VH) (Arm I (Fibrin Sealant))	njyemrquji(yosvetbuye) = dajcoqxolt gjtatqtggb (nkwuwwltsn, mpvvhnlmlr - sgoqbyhdke) View more	-	15 Mar 2013
				breast reconstruction (Arm II (Standard Electrocoagulation))	njyemrquji(yosvetbuye) = bjumvmpney gjtatqtggb (nkwuwwltsn, wbtssdwuhv - ugvrqpywxd) View more
ARVO2008	Not Applicable	-	114	Fibrin Sealant	kqvzpfmwwy(ujfvzgqllb) = yakxlluoqr prwbfregdk (ekkipekdxi ) View more	Positive	01 May 2008
Pubmed \| J Burn Care Res	Phase 3	Burns	138	Fibrin Sealant containing 4 IU/ml thrombin (FS 4IU VH S/D)	ugmirvdfae(uxttcbmwdl) = wrknujaxae kkxcmqcfwx (pmadjkdjkk ) View more	Positive	01 Mar 2008
				Fibrin Sealant	ugmirvdfae(uxttcbmwdl) = zbzovhjpyb kkxcmqcfwx (pmadjkdjkk ) View more