bisorb - Puyi (Shanghai) Biotechnology Co., Ltd.|puyi, Yipurun Corina

What is Bisorb ?

The Bisorb® is a revolutionary mode of topical drug delivery in the management of CRS, enabling targeted, sustained release of corticosteroids directly to sinonasal mucosa with simultaneous stenting of the postsurgical sinus cavity. Ethmoidal Placement Maxillary Placement Frontal Placement (Draf 3) The middle of the stent can be filled with "finger sleeve"

Frontal recess Placement Fixed mucosal flap

Clinical evidence-Clinical trial 50+

POST-OPERATIVE
INTERVENTION Conclusions: Bisorb^® Reduced Inflammation, Polyp formation and Need for Additional Surgery . improving surgical outcoms——ethmoid sinus

The Bisorb^® implant is comprised of a biodegradable PLG polymer matrix coated with 652 μg of mometasone furoate(MF) in a spring-like fashion, which is gradually eluted over a 30-day period. How It Works ?

Bisorb^® Drug-eluting Sinus Absorbable Stent System Specification

How It Works

SEVERE ADHESIONS
INFLAMMATION POLYPOSIS
Bioabsorbable steroid-eluting sinus stents for patients with refractory frontal diseases undergoing a revision Draf 3 procedure: a case series .
Case 1

Conclusions: Bisorb^® Drug-eluting sinus stents may decrease recurrence rates in revision cases where patients have extensive scarring or neo-osteogenesis of the operative field from prior Draf 2 or 3 procedures.

Conclusions: Bisorb^® Drug-eluting sinus stents reduce postoperative sinus mucosal edema, and eosinophilic inflammation, with persistent effects after stent disintegration,and are a good supplementary postsurgical treatment in patients with ECRSwNP.

improving surgical outcoms——frontal sinus

improving surgical outcoms——ECRS

Comparison of type 2 inflammatory mediators between the stent group and control group. ESS, endoscopic sinus surgery; ns, no significance.*P < .05. ****P < .0001. Conclusions: Bisorb^® Drug-eluting sinus stent is an effective treatment for olfactory deficits in patients with CRSwNP and may be related to the stent’s more effective reduction of local type 2 inflammatory mediators in the nasal cavity.

improving surgical outcoms——CA

Choanal Placement Anastomotic Placement (EN-DCR)

How It Works

(a)The shape of Bisorb® steroid-eluting stents.

(b)Intraoperative placement of bioabsorbable steroid-eluting stents during primary

repair of bilateral choanal atresia on a neonates.

Customized silicone stents made by silicon suction catheter and how it placed.

(d) The catheter was folded and a posterior fenestration

was created, where dorsally a bridge was left behind

which hinges around the vomer.

(e) A small connecting piece was sutured between both

nasal openings in order to prevent the postoperative

displacement.

Conclusions: The endoscopic septonasal flap technique can effectively expose and expand the choanal bony structure for repair of congenital choanal atresia in neonates and infants. The combined use of this technique along with Bisorb^® Drug-eluting sinus stents can help prevent the need for revision procedures and also against stent-related injuries.

improving surgical outcoms——EN-DCR

A prospective single-center & single-arm trial
A total of 31 patients (33 eyes) were included

FIGURE

Representative case demonstraing the appication of a steroid-eluting stent in endoscopic dacrvocystorhinostomy (EN-DCR). (A.B) Coronal and sagital computed tomography (CT) demonstrating left lacrimal passage obstruction and a previously implanted siicone intubation that has remained in the lacrimal passage long-term. (C) The maxilary frontal process was driled to expose the lacrimal sac, (D) Edematous lacrimal sac mucosa .(E) Residual silicone tube identifed in the lacrimal sac. (F) A steroid-eluting stent was implanted. (G) Endoscopic view at 2 weeks post-EN-DCR showing the stent with minor crusting around the neo-ostium. (H) Endoscopic view at 4 weeks post-EN-DCR showing a patent lacrima sac lumen with the stent having been removed, (l) Endoscopic view at 12 months postoperatively showing a patent lacrimal sac lumen.

At 12, 45 and 54 months, the neo-ostial patency rates were 96.97% (95% confidence interval [CI] 80.37%– 99.57%), 93.94% (95% CI 77.88%–98.45%) and 90.70% (95% CI 73.84%–96.91%), with 3 eyes experiencing ostial occlusion over 54 months.

Lacrimal irrigation success rates matched patency rates at 12 and 45 months (96.97% and 93.94%, identical 95% CIs), declining to 84.22% (95% CI 66.12%–93.12%) at 54 months in 5 eyes with irrigation failure.

Serum cortisol concentrations stayed within normal range, with no stents-related adverse events documented postoperatively.

Conclusions: Implantation of steroid-eluting sinonasal stents during EN-DCR achieves favorable long-term safety and efficacy by preserving neo-ostial patency. Nevertheless, dedicated stents anatomically tailored to the neo-ostium of EN-DCR are required to further optimize surgical outcomes.

The European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2020)
United States: International consensus statement on allergy and rhinology: rhinosinusitis 2021

Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis(CPOS 2018 & CPOS 2024)

“Endoscopic sinus surgery (ESS) is only a component of CRS treatment. Surgery cannot completely remove or change the inflamed sinus mucosa. Continuous postoperative care and comprehensive drug therapy can promote the gradual recovery of sinus mucosal morphology and function. “

” If local edema or polyp regeneration occurs in the sinus mucosa(especially the frontal recess), it can be treated by local placement of glucocorticoid-containing gelatin sponge, local simultaneous washing of glucocorticoid-diluent, or placement of glucocorticoid-drug sustained-release stent in the sinus cavity.”

References FIGURE 2
Typical endoscopic views of the bilateral nasal cavity of the control (A-E) and treatment sides (F-J) of same patient at weeks 0.2.4.8. and 12.

Model Specification Table

Model	Diameter (mm)	Height (mm)	Conveyor angles	Frontal sinus	Sphenoid sinus	Ethmoid sinus	maxillary sinus	Draf 3
SDES2514-1	25	14	10°		√	√
SDES2514-2	25	14	70°	√
SDES2514-3	25	14	110°				√
SDES2516-1	25	16	10°		√	√
SDES2516-2	25	16	70°	√
SDES2516-3	25	16	110°				√
SDES4012-1	40	12	10°		√	√		√
SDES4016-1	40	16	10°		√	√		√
SDES4212-1	42	12	10°			√		√
SDES4212-2	42	12	70°	√		√		√
SDES4214-1	42	14	10°			√		√
SDES4216-1	42	16	10°			√		√

Table 1. Patient Demographic and Clinical Characteristics

Table 1. Summary of the demographic and clinical characteristics of patients who underwent a Draf 3 with steroid eluting sinus stent.

No.	Age (years)	Gender	Diagnosis	History of previous surgery	Symptoms	Pre-op CT findings	Pre-op endoscopic view
1	37	Male	Recurrent frontal sinusitis Nasal polyps Asthma	4 (1 FESS, 2 Draf 3 procedure and 1 balloon dilation)	Headache	Frontal neo-ost- ium stenosis	Narrowed frontal neo- ostium with puru- lent nasal discharge
2	21	Female	Recurrent frontal rhinosinusitis	3 (1 FESS, 1 Draf 2b procedure and 1 Draf 3 procedure)	Headache	Frontal neo-ostium stenosis with neo- osteogenesis	Frontal neo-ost- ium closed
3	53	Male	Recurrent frontal rhinosinusitis	2 (1 FESS and 1 Draf 2a procedure)	Headache	Frontal neo-ostium stenosis with neo- osteogenesis	Narrowed frontal neo- ostium with puru- lent nasal discharge
4	62	Male	Frontal mucocele after resection of inverted papilloma	7 (1 Draf 3 procedure, 6 tumor resection)	Asymptomatic	Mucocele formation with neo- osteogenesis	Frontal neo-ost- ium closed
5	57	Male	Frontal mucocele after resection of meningioma	2 (1 craniotomy and Draf 3 procedure)	Asymptomatic	Mucocele formation with neo- osteogenesis	Frontal neo-ost- ium closed
6	59	Female	Frontal mucocele after resection of inverted papilloma	2 (1 lateral rhinotomy, 1 Draf 3)	Headache	Frontal neo-ostium closed with neo- osteogenesis	Frontal neo-ost- ium closed
7	27	Female	Frontal mucocele after resection of ossify- ing fibroma	2 Draf 2b procedure	Headache	Frontal neo-ostium closed with neo- osteogenesis	Frontal neo-ost- ium closed

CONSORT Flow Diagram

Enrollment

Allocation

Follow-up

Analysis

Assessed for eligibility

(N=187)

Excluded(N=4)

did not meet inclusion

criteria(n=4)

Assessed for eligibility

(N=183)

Allocated to treatment(N=183):

Received allocated intervention

(N=183)

Did not received intervention(N=0)

Allocated to control(N=183):

Received allocated intervention

(N=183)

Did not received intervention(N=0)

Completed day 30 after ESS

follow-up(N=181):

Lost of visit (N=2)

Completed day 30 after ESS

follow-up(N=181):

Lost of visit (N=2)

Completed analysis of the data

(N=181):

Missing data (N=0)

Completed analysis of the data

(N=181):

Missing data (N=0)

Table 2. Revision surgeries

Table 2. Revision surgeries.

Patients	Previous surgery	Year of previous surgery	Time to failure	Indication for revision	Revision surgery	Follow-up, month	Outcome	Further revision
1	Draf 3	2014	3 months	FNO stenosis	Draf 3	27.5	Sinus ostium open	No
2	Draf 3	2013	24 months	FNO closed	Draf 3	11.6	Sinus ostium open	No
3	Draf 2a	2009	72 months	FNO stenosis	Draf 3	33.8	Sinus ostium open	No
4	Draf 3	2015	36 months	FNO closed	Draf 3	5.9	Sinus ostium open	No
5	Draf 3	2015	26 months	FNO closed	Draf 3	5.2	Sinus ostium open	No
6	Draf 3	2014	24 months	FNO closed	Draf 3	9.6	Sinus ostium open	No
7	Draf 2b	2014	6 months	FNO closed	Draf 3	11.6	Sinus ostium open	No

FNO: frontal neo-ostium.

Table 2 Postoperative data of Silicone stents Bioabsorbable steroid-eluting stents group

Parameter	Silicone stents group (n = 22)	Bioabsorbable steroid-eluting stents group (n = 15)	Statistical test value	P-value
Average operative duration (minutes)
Mean±SD	97.46±15.37	83.49±19.16	t=13.733	0.000^*
Number of procedures
Mean±SD	2.04±0.64	1.00±0.00	t=82.689	0.000^*
Hospital length of stay^▲ (days)
Mean±SD	12.8±3.22	7.67±3.91	t=15.082	0.000^*
Restenosis (n(%))	2/22 (9.1%)	–	–	–
Timing of complications (days)	31.33±5.12	–	–	–
Complications (n(%))	3/22(13.6%)	–	–	–
Granulations (n(%))	1/22(4.5%)	–	–	–
Damage of columella and alars (n(%))	1/22 (4.5%)	–	–	–
Posterior nasal septal injury (n(%))	1/22 (4.5%)	–	–	–

^* Indicates statistical significance between groups. SD=standard deviation; t=t-test

^▲ Total length of hospitalization related to CA surgeries

Indications, Safety, and Warnings

TABLE I-4 Grade A/B Evidence-based Recommendations

TABLE I-4　Grade A/B evidence-based recommendations for medical management of CRS

Intervention	Grade	Benefit	Harm	Cost	Benefit-Harm Assessment	Policy Level
CRSwNP: Corticosteroid Eluting Implants	A	Reduction in ethmoid obstruction, polyp grade, decreased need for revision ESS, reduced nasal obstruction scores	No findings of increased risk of elevated intraocular pressure or cataracts	Moderate to High	Benefits appear to outweigh harm	Option: Corticosteroid-eluting implants can be considered as an option in a previously operated ethmoid cavity with recurrent nasal polyps

Table 1.6.1. Treatment evidence and recommendations for adults with chronic rhinosinusitis.

Therapy	Level of evidence	GRADE recommendation
Corticosteroid-eluting implants	1a	The placement of corticosteroid-eluting sinus implants in the ethmoid of patients with recurrent polyposis after sinus surgery has a significant but small (0.3 on a 0-3 scale) impact on nasal obstruction but significantly reduces the need for surgery and reduces nasal polyp score. Based on the moderate to high quality of the evidence the steering group considered the use of corticosteroid-eluting sinus implants in the ethmoid an option.

Male, 37-year-old, recurrent frontal rhinosinusitis;
Surgery history: 1 FESS, 2 Draf 3 procedures and 1 balloon dilation;
Preoperative CT scans (A-C)
Postoperative endoscopic view of the frontal sinus, 8 months postoperatively (D) The arrow marks the narrowed frontal neo-ostium. the patient presented with a headache. SP: septum.

A prospective , multicenter ,randomized ,
intrapatient-controlled trial
Ninety-eight patients were enrolled
Eosinophilic chronic rhinosinusitis with nasal
polyps—— refractory CRS
Treatment side—Bisorb^® stent side
Control side—non-stent side
Comparison of the tissue eosinophilia
volumetric, nasal obstruction, and total
nasal symptom scores , stent side was
lower than the control side

FIGURE 3 Endoscopic scores of patients' bilateral nasal cavity at weeks 2, 4, 8, and 12 postoperatively. (A) Lund-Kennedy (LK) score. (B) Polyp score. (C) Edema score. (D) Crusting score. (E) Discharge score. (F) Scarring score. Bars and error bars represent means and standard errors. Wilcoxon test was performed, with *p < 0.05, **p < 0.01, and ***p < 0.001. FIGURE 4 Comparison of the computed tomography (CT) findings between bilateral nasal cavities at week 8 postoperatively.Three-dimensional (3D) volumetric score of the ethmoid (A) and frontal (F) sinuses. Volumetric segmentation of the ethmoid sinus in the coronal (B), axial (C), and sagittal (D, E) views. Volumetric segmentation of the frontal sinus in the coronal (G), axial (H), and sagittal (I, J) views. White asterisk indicates the treatment side. The control side is unmarked. FIGURE 5 Comparison of histopathologic differences between bilateral nasal cavities at week 4 postoperatively. (A) Comparison of the eosinophil count of the ethmoid sinus mucosa between bilateral nasal cavities. (B-E) Histologic evaluation of the bilateral ethmoid sinus mucosa in the same patient (hematoxylin and eosin stain; ×400 magnification). (B, C) Representative images of treatment side tissue at presurgery and 4 weeks postsurgery, respectively. (D, E) Representative images of control side tissue at presurgery and 4 weeks postsurgery,respectively.

Enrollment

Allocation

Follow-up

Analysis

Patients with CRSwNP-associated olfactory dysfunction (n=60)

Excluded (n=0)

Allocated to two groups based on choices of patients (n=60)

Allocated to stent group (n=30):

Perform endoscopic sinus surgery (n=30)
Placed the steroid-eluting stents (n=30)

Allocated to control group (n=30):

Perform endoscopic sinus surgery (n=30)
Not placed the steroid-eluting stents (n=30)

Lost to follow-up (n=0)

Withdraw consents (n=0)

Lost to follow-up (n=1)

Withdraw consents (n=0)

Completed the study and data analysis

(n=30)

Completed the study and data analysis

(n=29)

(a) (b) (c) (d) (e)

A retrospective clinical trial
N=37
neonates and infants of the congenital choanal
atresia
22 patients —silicone stents group
15 patients —Bisorb^® stents group
Comparison of the average operative
duration and the hospital length of stay
were shorter in Bisorb^® stents group
Need secondary general anesthesia to
remove the silicone stents

Pre-ESS and post-ESS olfactory Visual Analogue Scale (VAS), T&T olfactometer score, SNOT-22 scores, and Lund-Kennedy scores between the stent group and control group. ns, no significance; ESS, endoscopic sinus surgery.*p < .05. improving surgical outcoms——Olfactory Dysfunction

Why is the 'steroid-eluting stent' recommended with the high level of evidence for CRS ? Steroid-eluting stents have been shown to significantly reduce the rate of reoperation and lower postoperative nasal polyp scores, and their application is strongly recommended by the ICAR-RS 2021, EPOS 2020, as well as CPOS 2018 and 2024 clinical guidelines.
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【26-52】......

A prospective ,randomized ,multicenter , controlled, single-blinded clinical trial

N=181(CRS)

Treatment side—received a Bisorb^® drug-eluting sinus absorbable stent in one ethmoid sinus cavity. Control side—a Nasopore package.

Follow-up 90 days, polyp formation, severe adhesion and the need for postoperative surgical intervention was significantly lower on the stents sides

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